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Comparative Study on the Effectiveness, Comfort and Compliance of HFNC and Noninvasive Mechanical Ventilation BiPAP Mode in the Treatment of Hypoxemia Patients

Primary Purpose

Hypoxemia

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Non-invasive BiPAP ventilation
HFNC
Sponsored by
Qilu Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoxemia focused on measuring Hypoxemia, High-flow nasal cannula, Mechanical ventilation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: . PaO2 < 60mmHg, SpO2 < 92%(without oxygen inhalation); Mild to moderate type I respiratory failure (100 mmHg < PaO/Fi02≤300 mmHg); Exclusion Criteria: Missing primary outcome measures Terminal stage of various chronic diseases; The patient or family members do not agree to NIV or HFNI treatment; Severe type I respiratory failure (PaO2/Fi02≤100 mmHg) Ventilation dysfunction (pH<7.30) Contradictory breathing The patient abandons or terminates treatment, automatically discharges or transfers to another hospital; Serious diseases, such as organ function damage and sepsis;

Sites / Locations

  • Qilu Hospital of Shandong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Non-invasive BiPAP ventilation treatment group

HFNC treatment group

Arm Description

Patients were first treated with HFNC on the basis of conventional treatment. The initial parameters were temperature: 31-37 °C, flow rate: 30-40 L/min, maintaining SpO2>92%, adjusting oxygen concentration according to blood oxygen saturation, and treatment duration was 24 h. After 24 h, patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge

On the basis of conventional treatment, patients were first administered a noninvasive ventilator with the following initial parameters. BiPAP mode with an initial inspiratory pressure (IPAP) of 8-15 cmH2O and an initial expiratory pressure (EPAP) of 4-8 cmH2O. These parameters were adjusted according to the patient's specific conditions. After 24 hours of treatment, patients received HFNC until discharge.

Outcomes

Primary Outcome Measures

HR
Heart rate
HR
Heart rate
HR
Heart rate
HR
Heart rate
HR
Heart rate
HR
Heart rate
HR
Heart rate
HR
Heart rate
HR
Heart rate
HR
Heart rate
HR
Heart rate
HR
Heart rate
HR
Heart rate
HR
Heart rate
HR
Heart rate
HR
Heart rate
HR
Heart rate
HR
Heart rate
RR
Respiratory rate
RR
Respiratory rate
RR
Respiratory rate
RR
Respiratory rate
RR
Respiratory rate
RR
Respiratory rate
RR
Respiratory rate
RR
Respiratory rate
RR
Respiratory rate
RR
Respiratory rate
RR
Respiratory rate
RR
Respiratory rate
RR
Respiratory rate
RR
Respiratory rate
RR
Respiratory rate
RR
Respiratory rate
RR
Respiratory rate
RR
Respiratory rate
BP
Blood pressure (Includes systolic and diastolic blood pressure)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
BP
Blood pressure (Includes systolic and diastolic blood pressure)
SO2
Pulse oxygen saturation
SO2
Pulse oxygen saturation
SO2
Pulse oxygen saturation
SO2
Pulse oxygen saturation
SO2
Pulse oxygen saturation
SO2
Pulse oxygen saturation
SO2
Pulse oxygen saturation
SO2
Pulse oxygen saturation
SO2
Pulse oxygen saturation
SO2
Pulse oxygen saturation
SO2
Pulse oxygen saturation
SO2
Pulse oxygen saturation
SO2
Pulse oxygen saturation
SO2
Pulse oxygen saturation
SO2
Pulse oxygen saturation
SO2
Pulse oxygen saturation
SO2
Pulse oxygen saturation
SO2
Pulse oxygen saturation
pH
Degree of pH in arterial blood
pH
Degree of pH in arterial blood
pH
Degree of pH in arterial blood
pH
Degree of pH in arterial blood
pH
Degree of pH in arterial blood
pH
Degree of pH in arterial blood
pH
Degree of pH in arterial blood
pH
Degree of pH in arterial blood
pH
Degree of pH in arterial blood
pH
Degree of pH in arterial blood
PaO2
Partial arterial oxygen pressure
PaO2
Partial arterial oxygen pressure
PaO2
Partial arterial oxygen pressure
PaO2
Partial arterial oxygen pressure
PaO2
Partial arterial oxygen pressure
PaO2
Partial arterial oxygen pressure
PaO2
Partial arterial oxygen pressure
PaO2
Partial arterial oxygen pressure
PaO2
Partial arterial oxygen pressure
PaO2
Partial arterial oxygen pressure
SaO2
Arterial oxygen saturation
SaO2
Arterial oxygen saturation
SaO2
Arterial oxygen saturation
SaO2
Arterial oxygen saturation
SaO2
Arterial oxygen saturation
SaO2
Arterial oxygen saturation
SaO2
Arterial oxygen saturation
SaO2
Arterial oxygen saturation
SaO2
Arterial oxygen saturation
SaO2
Arterial oxygen saturation
PCO2
partial pressure of carbon dioxide in arterial blood
PCO2
partial pressure of carbon dioxide in arterial blood
PCO2
partial pressure of carbon dioxide in arterial blood
PCO2
partial pressure of carbon dioxide in arterial blood
PCO2
partial pressure of carbon dioxide in arterial blood
PCO2
partial pressure of carbon dioxide in arterial blood
PCO2
partial pressure of carbon dioxide in arterial blood
PCO2
partial pressure of carbon dioxide in arterial blood
PCO2
partial pressure of carbon dioxide in arterial blood
PCO2
partial pressure of carbon dioxide in arterial blood
FiO2
Fraction of inspiration O2
FiO2
Fraction of inspiration O2
FiO2
Fraction of inspiration O2
FiO2
Fraction of inspiration O2
FiO2
Fraction of inspiration O2
FiO2
Fraction of inspiration O2
FiO2
Fraction of inspiration O2
FiO2
Fraction of inspiration O2
FiO2
Fraction of inspiration O2
FiO2
Fraction of inspiration O2
Lac
Lactic acid in arterial blood
Lac
Lactic acid in arterial blood
Lac
Lactic acid in arterial blood
Lac
Lactic acid in arterial blood
Lac
Lactic acid in arterial blood
Lac
Lactic acid in arterial blood
Lac
Lactic acid in arterial blood
Lac
Lactic acid in arterial blood
Lac
Lactic acid in arterial blood
Lac
Lactic acid in arterial blood
Glu
Arterial blood glucose in arterial blood
Glu
Arterial blood glucose in arterial blood
Glu
Arterial blood glucose in arterial blood
Glu
Arterial blood glucose in arterial blood
GLu
Arterial blood glucose in arterial blood
Glu
Arterial blood glucose in arterial blood
Glu
Arterial blood glucose in arterial blood
Glu
Arterial blood glucose in arterial blood
Glu
Arterial blood glucose in arterial blood
Glu
Arterial blood glucose in arterial blood
A-aDO2
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
A-aDO2
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
A-aDO2
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
A-aDO2
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
A-aDO2
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
A-aDO2
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
A-aDO2
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
A-aDO2
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
A-aDO2
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
A-aDO2
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
BE
Base excess in arterial blood
BE
Base excess in arterial blood
BE
Base excess in arterial blood
BE
Base excess in arterial blood
BE
Base excess in arterial blood
BE
Base excess in arterial blood
BE
Base excess in arterial blood
BE
Base excess in arterial blood
BE
Base excess in arterial blood
BE
Base excess in arterial blood
RI
Respiratory Index
RI
Respiratory Index
RI
Respiratory Index
RI
Respiratory Index
RI
Respiratory Index
RI
Respiratory Index
RI
Respiratory Index
RI
Respiratory Index
RI
Respiratory Index
RI
Respiratory Index
Arterial blood HCO3- concentration
Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration
Arterial blood HCO3- concentration
Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration
Arterial blood HCO3- concentration
Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration
Arterial blood HCO3- concentration
Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration
Arterial blood HCO3- concentration
Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration
Arterial blood HCO3- concentration
Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration
Arterial blood HCO3- concentration
Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration
Arterial blood HCO3- concentration
Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration
Arterial blood HCO3- concentration
Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration
Arterial blood HCO3- concentration
Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration
Arterial blood K+ concentration
Arterial blood K+ concentration
Arterial blood K+ concentration
Arterial blood K+ concentration
Arterial blood K+ concentration
Arterial blood K+ concentration
Arterial blood K+ concentration
Arterial blood K+ concentration
Arterial blood K+ concentration
Arterial blood K+ concentration
Arterial blood K+ concentration
Arterial blood K+ concentration
Arterial blood K+ concentration
Arterial blood K+ concentration
Arterial blood K+ concentration
Arterial blood K+ concentration
Arterial blood K+ concentration
Arterial blood K+ concentration
Arterial blood K+ concentration
Arterial blood K+ concentration
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
Arterial blood Ca2+ concentration
Arterial blood Na+ concentration
Arterial blood Na+ concentration
Arterial blood Na+ concentration
Arterial blood Na+ concentration
Arterial blood Na+ concentration
Arterial blood Na+ concentration
Arterial blood Na+ concentration
Arterial blood Na+ concentration
Arterial blood Na+ concentration
Arterial blood Na+ concentration
Arterial blood Na+ concentration
Arterial blood Na+ concentration
Arterial blood Na+ concentration
Arterial blood Na+ concentration
Arterial blood Na+ concentration
Arterial blood Na+ concentration
Arterial blood Na+ concentration
Arterial blood Na+ concentration
Arterial blood Na+ concentration
Arterial blood Na+ concentration
TCO2
Total carbon dioxide in arterial blood
TCO2
Total carbon dioxide in arterial blood
TCO2
Total carbon dioxide in arterial blood
TCO2
Total carbon dioxide in arterial blood
TCO2
Total carbon dioxide in arterial blood
TCO2
Total carbon dioxide in arterial blood
TCO2
Total carbon dioxide in arterial blood
TCO2
Total carbon dioxide in arterial blood
TCO2
Total carbon dioxide in arterial blood
TCO2
Total carbon dioxide in arterial blood
HCT
hematocrit in arterial blood
HCT
hematocrit in arterial blood
HCT
hematocrit in arterial blood
HCT
hematocrit in arterial blood
HCT
hematocrit in arterial blood
HCT
hematocrit in arterial blood
HCT
hematocrit in arterial blood
HCT
hematocrit in arterial blood
HCT
hematocrit in arterial blood
HCT
hematocrit in arterial blood
tHbc
Total hemoglobin in arterial blood
tHbc
Total hemoglobin in arterial blood
tHbc
Total hemoglobin in arterial blood
tHbc
Total hemoglobin in arterial blood
tHbc
Total hemoglobin in arterial blood
tHbc
Total hemoglobin in arterial blood
tHbc
Total hemoglobin in arterial blood
tHbc
Total hemoglobin in arterial blood
tHbc
Total hemoglobin in arterial blood
tHbc
Total hemoglobin in arterial blood
height
m
Weight
Kg
gender
Male and female
age
year
WBC
The number of white blood cells in venous blood
WBC
The number of white blood cells in venous blood
NEU
The number of Neutrophil granulocyte in venous blood
NEU
The number of Neutrophil granulocyte in venous blood
LYM
The number of Venous blood lymphocytes in venous blood
LYM
The number of Venous blood lymphocytes in venous blood
EOS
The number of Venous blood eosinophils in venous blood
EOS
The number of Venous blood eosinophils in venous blood
BAS
The number of Venous blood Basophils in venous blood
BAS
The number of Venous blood Basophils in venous blood
MON
The number of Venous blood Monocyte cell in venous blood
MON
The number of Venous blood Monocyte cell in venous blood
RBC
The number of red blood cells in venous blood
RBC
The number of red blood cells in venous blood
HGB
The number of haemoglobin in venous blood
HGB
The number of haemoglobin in venous blood
HCT
hematocrit in venous blood
HCT
hematocrit in venous blood
MCV
Mean Corpuscular Volume in venous blood
MCV
Mean Corpuscular Volume in venous blood
MCH
Mean Corpuscular Haemoglobin Concentration in venous blood
MCH
Mean Corpuscular Haemoglobin Concentration in venous blood
RDW
red blood cell distribution width in venous blood
RDW
red blood cell distribution width in venous blood
PLT
platelet in venous blood
PLT
platelet in venous blood
PDW
Platelet distributionwidth in venous blood
PDW
Platelet distributionwidth in venous blood
MPV
Mean Platelet Volume in venous blood
MPV
Mean Platelet Volume in venous blood
plateletcrit
plateletcrit in venous blood
plateletcrit
plateletcrit in venous blood
CRP
C-reactive protein in venous blood
CRP
C-reactive protein in venous blood
PCT
Procalcitonin in venous blood
PCT
Procalcitonin in venous blood
NT-proBNP
NT-proBNP in venous blood
NT-proBNP
NT-proBNP in venous blood
ESR
erythrocytesedimentationrate in venous blood
ESR
erythrocytesedimentationrate in venous blood
PT
prothrombin time in venous blood
PT
prothrombin time in venous blood
APTT
activated partial thromboplastin time in venous blood
APTT
activated partial thromboplastin time in venous blood
TT
Thrombin time in venous blood
TT
Thrombin time in venous blood
D-Di
D-Dimer in venous blood
D-Di
D-Dimer in venous blood
ALT
alanine transaminase in venous blood
ALT
alanine transaminase in venous blood
AST
Aspartate Transaminase in venous blood
AST
Aspartate Transaminase in venous blood
PA
Serum prealbumin in venous blood
PA
Serum prealbumin in venous blood
TP
Total serum protein in venous blood
TP
Total serum protein in venous blood
ALB
Albumin protein in venous blood
ALB
Albumin protein in venous blood
GLB
Globulin globulin in venous blood
GLB
Globulin globulin in venous blood
Cr
creatinine in venous blood
Cr
creatinine in venous blood
BUN
Urea nitrogen in venous blood
BUN
Urea nitrogen in venous blood
Cys-C
Cystatin C in venous blood
Cys-C
Cystatin C in venous blood
eGFR
Estimate glomerular filtration rate in venous blood
eGFR
Estimate glomerular filtration rate in venous blood
Respiratory support time
Daily respiratory support time after patients were enrolled in the clinical study,h/Day
Relief time for dyspnea
Remission time of dyspnea after intervention
Tracheal intubation
Yes or No
Stay in the ICU
Yes or No
Complications
Facial injury, flatulence,Gastroesophageal reflux,Dry throat, sore throat,pneumothorax,Eye irritation discomfort,Low blood pressure.
Outcome of disease
Get better, get worse, die
Total bilirubin
Serum total bilirubin in venous blood
Total bilirubin
Serum total bilirubin in venous blood
DBIL
Direct bilirubin in venous blood
DBIL
Direct bilirubin in venous blood
IBIL
Indirect bilirubin in venous blood
IBIL
Indirect bilirubin in venous blood
Diaphragm mobility
The patient is lying in a flat position. The convex array probe is placed at the junction of the anterior axillary line, midclavicular line, and rib margin (bilaterally), with the probe mark facing outward and downward for measurement.
Diaphragm mobility
The patient is lying in a flat position. The convex array probe is placed at the junction of the anterior axillary line, midclavicular line, and rib margin (bilaterally), with the probe mark facing outward and downward for measurement.
Diaphragm mobility
The patient is lying in a flat position. The convex array probe is placed at the junction of the anterior axillary line, midclavicular line, and rib margin (bilaterally), with the probe mark facing outward and downward for measurement.
Diaphragm mobility
The patient is lying in a flat position. The convex array probe is placed at the junction of the anterior axillary line, midclavicular line, and rib margin (bilaterally), with the probe mark facing outward and downward for measurement.
Diaphragm thickness
Includes end-inspiratory diaphragm thickness and end-expiratory diaphragm thickness;The patient is lying flat on the bed. A linear array probe is placed in the mid-axillary line or between the anterior and mid-axillary lines between the eighth and tenth ribs, and measurements are taken.
Diaphragm thickness
Includes end-inspiratory diaphragm thickness and end-expiratory diaphragm thickness;The patient is lying flat on the bed. A linear array probe is placed in the mid-axillary line or between the anterior and mid-axillary lines between the eighth and tenth ribs, and measurements are taken.
Diaphragm thickness
Includes end-inspiratory diaphragm thickness and end-expiratory diaphragm thickness;The patient is lying flat on the bed. A linear array probe is placed in the mid-axillary line or between the anterior and mid-axillary lines between the eighth and tenth ribs, and measurements are taken.
Diaphragm thickness
Includes end-inspiratory diaphragm thickness and end-expiratory diaphragm thickness;The patient is lying flat on the bed. A linear array probe is placed in the mid-axillary line or between the anterior and mid-axillary lines between the eighth and tenth ribs, and measurements are taken.

Secondary Outcome Measures

Patient compliance to the treatment
Patients were managed for compliance with the treatment.Dependent judgment Complete dependence: patients actively cooperate with medical staff in treatment Partial dependence: in most cases, patients can cooperate with the treatment, and in a few cases, patients resist the treatment but receive treatment after being enlightened by the medical staff. Non-dependence: patients have strong resistance and resistance, so that they are unable to use ventilators or nasal high-flow humidification instruments.
Kolcaba Comfort Scale (GCQ) assessment assesses patient comfort
Kolcaba's General Comfort Questionnaire (GCQ) is composed of 28 items from 4 dimensions: physiological, psychological, spiritual, socio-cultural and environmental. The modification Scale adopts 1 to 4Likert Scale, with 1 indicating strongly disagree and 4 indicating strongly agree. In the negative question, 1 means strongly agree and 4 means strongly disagree. A higher score indicates more comfort.
Dyspnea rating scale
According to the degree of dyspnea and symptoms of the patient, the lowest score is 0, the highest score is 10.

Full Information

First Posted
September 19, 2022
Last Updated
March 13, 2023
Sponsor
Qilu Hospital of Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT05784636
Brief Title
Comparative Study on the Effectiveness, Comfort and Compliance of HFNC and Noninvasive Mechanical Ventilation BiPAP Mode in the Treatment of Hypoxemia Patients
Official Title
Comparative Study on the Effectiveness, Comfort and Compliance of High-flow Nasal Oxygen Therapy and Noninvasive Mechanical Ventilation BiPAP Mode in the Treatment of Hypoxemia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 6, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Hospital of Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients who met the inclusion criteria were included and signed an informed consent form, which complied with the requirements of the ethics committee of our unit. All subjects were inpatients. Subjects were randomized into two groups. patients in group A were first treated with HFNC on top of conventional treatment, and after 24 hours, patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge. patients in group B were treated with a non-invasive ventilator on top of conventional treatment, and after 24 hours of treatment, patients were treated with HFNC until discharge. Patient information was collected during treatment.
Detailed Description
Patients who met the inclusion criteria were included and signed the informed consent, which met the requirements of the ethics committee of our unit. All subjects were hospitalized patients. Subjects were randomly divided into two groups. Patients in group A were treated with HFNC on the basis of conventional treatment. The initial parameters were: temperature:31-37℃, flow: 30-40l /min, SpO2 > 92% maintained, the oxygen concentration was adjusted according to the patient's oxygen saturation, and the treatment time was 24h. Twenty-four hours later, the patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge. On the basis of conventional treatment, patients in group B were given a non-invasive ventilator with the following initial parameters: BiPaP mode, initial inspiratory pressure (IPAP) of 8-15cmH2O, initial expiratory pressure (EPAP) of 4-8cmH2O. The parameters were adjusted according to the specific conditions of the patients. After 24 hours of treatment, the patient was treated with HFNC until discharge. Patient information was collected during treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxemia
Keywords
Hypoxemia, High-flow nasal cannula, Mechanical ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
243 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-invasive BiPAP ventilation treatment group
Arm Type
Experimental
Arm Description
Patients were first treated with HFNC on the basis of conventional treatment. The initial parameters were temperature: 31-37 °C, flow rate: 30-40 L/min, maintaining SpO2>92%, adjusting oxygen concentration according to blood oxygen saturation, and treatment duration was 24 h. After 24 h, patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge
Arm Title
HFNC treatment group
Arm Type
Experimental
Arm Description
On the basis of conventional treatment, patients were first administered a noninvasive ventilator with the following initial parameters. BiPAP mode with an initial inspiratory pressure (IPAP) of 8-15 cmH2O and an initial expiratory pressure (EPAP) of 4-8 cmH2O. These parameters were adjusted according to the patient's specific conditions. After 24 hours of treatment, patients received HFNC until discharge.
Intervention Type
Device
Intervention Name(s)
Non-invasive BiPAP ventilation
Other Intervention Name(s)
HFNC
Intervention Description
Patients were first treated with HFNC (High-flow nasal cannula) on the basis of conventional treatment. The initial parameters were temperature: 31-37 °C, flow rate: 30-40l /min, maintaining SpO2>92%, adjusting oxygen concentration according to blood oxygen saturation, and treatment duration was 24 h. After 24 h, patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge.
Intervention Type
Device
Intervention Name(s)
HFNC
Other Intervention Name(s)
Non-invasive BiPAP ventilation
Intervention Description
On the basis of conventional treatment, patients were first administered a noninvasive ventilator with the following initial parameters. BiPAP mode with an initial inspiratory pressure (IPAP) of 8-15 cmH2O and an initial expiratory pressure (EPAP) of 4-8 cmH2O. These parameters were adjusted according to the patient's specific conditions. After 24 hours of treatment, patients received HFNC (High-flow nasal cannula) until discharge.
Primary Outcome Measure Information:
Title
HR
Description
Heart rate
Time Frame
At the time of enrollment in the clinical study
Title
HR
Description
Heart rate
Time Frame
On the first hour after enrollment
Title
HR
Description
Heart rate
Time Frame
On the second hour after enrollment
Title
HR
Description
Heart rate
Time Frame
On the 6th hour after enrollment
Title
HR
Description
Heart rate
Time Frame
On the 12th hour after enrollment
Title
HR
Description
Heart rate
Time Frame
On the 24th hour after enrollment
Title
HR
Description
Heart rate
Time Frame
On the 25th hour after enrollment (On the first hour after crossover)
Title
HR
Description
Heart rate
Time Frame
On the 26th hour after enrollment (On the second hour after crossover)
Title
HR
Description
Heart rate
Time Frame
On the 30th hour after enrollment (On the 6th hour after crossover)
Title
HR
Description
Heart rate
Time Frame
On the 36th hour after enrollment (On the 12th hour after crossover)
Title
HR
Description
Heart rate
Time Frame
On the 48th hour after enrollment (On the 24th hour after crossover)
Title
HR
Description
Heart rate
Time Frame
On the third day after enrollment (On the 48th hour after crossover)
Title
HR
Description
Heart rate
Time Frame
On the 4th day after enrollment (On the third day after crossover)
Title
HR
Description
Heart rate
Time Frame
On the 5th day after enrollment (On the 4th day after crossover)
Title
HR
Description
Heart rate
Time Frame
On the 6th day after enrollment (On the 5th day after crossover)
Title
HR
Description
Heart rate
Time Frame
On the 7th day after enrollment (On the 6th day after crossover)
Title
HR
Description
Heart rate
Time Frame
On the 8th day after enrollment (On the 7th day after crossover)
Title
HR
Description
Heart rate
Time Frame
On the 9th day after enrollment (On the 8th day after crossover)
Title
RR
Description
Respiratory rate
Time Frame
At the time of enrollment in the clinical study
Title
RR
Description
Respiratory rate
Time Frame
On the first hour after enrollment
Title
RR
Description
Respiratory rate
Time Frame
On the second hour after enrollment
Title
RR
Description
Respiratory rate
Time Frame
On the 6th hour after enrollment
Title
RR
Description
Respiratory rate
Time Frame
On the 12th hour after enrollment
Title
RR
Description
Respiratory rate
Time Frame
On the 24th hour after enrollment
Title
RR
Description
Respiratory rate
Time Frame
On the 25th hour after enrollment (On the first hour after crossover)
Title
RR
Description
Respiratory rate
Time Frame
On the 26th hour after enrollment (On the second hour after crossover)
Title
RR
Description
Respiratory rate
Time Frame
On the 30th hour after enrollment (On the 6th hour after crossover)
Title
RR
Description
Respiratory rate
Time Frame
On the 36th hour after enrollment (On the 12th hour after crossover)
Title
RR
Description
Respiratory rate
Time Frame
On the 48th hour after enrollment (On the 24th hour after crossover)
Title
RR
Description
Respiratory rate
Time Frame
On the third day after enrollment (On the 48th hour after crossover)
Title
RR
Description
Respiratory rate
Time Frame
On the 4th day after enrollment (On the third day after crossover)
Title
RR
Description
Respiratory rate
Time Frame
On the 5th day after enrollment (On the 4th day after crossover)
Title
RR
Description
Respiratory rate
Time Frame
On the 6th day after enrollment (On the 5th day after crossover)
Title
RR
Description
Respiratory rate
Time Frame
On the 7th day after enrollment (On the 6th day after crossover)
Title
RR
Description
Respiratory rate
Time Frame
On the 8th day after enrollment (On the 7th day after crossover)
Title
RR
Description
Respiratory rate
Time Frame
On the 9th day after enrollment (On the 8th day after crossover)
Title
BP
Description
Blood pressure (Includes systolic and diastolic blood pressure)
Time Frame
At the time of enrollment in the clinical study
Title
BP
Description
Blood pressure (Includes systolic and diastolic blood pressure)
Time Frame
On the first hour after enrollment
Title
BP
Description
Blood pressure (Includes systolic and diastolic blood pressure)
Time Frame
On the second hour after enrollment
Title
BP
Description
Blood pressure (Includes systolic and diastolic blood pressure)
Time Frame
On the 6th hour after enrollment
Title
BP
Description
Blood pressure (Includes systolic and diastolic blood pressure)
Time Frame
On the 12th hour after enrollment
Title
BP
Description
Blood pressure (Includes systolic and diastolic blood pressure)
Time Frame
On the 24th hour after enrollment
Title
BP
Description
Blood pressure (Includes systolic and diastolic blood pressure)
Time Frame
On the 25th hour after enrollment (On the first hour after crossover)
Title
BP
Description
Blood pressure (Includes systolic and diastolic blood pressure)
Time Frame
On the 26th hour after enrollment (On the second hour after crossover)
Title
BP
Description
Blood pressure (Includes systolic and diastolic blood pressure)
Time Frame
On the 30th hour after enrollment (On the 6th hour after crossover)
Title
BP
Description
Blood pressure (Includes systolic and diastolic blood pressure)
Time Frame
On the 36th hour after enrollment (On the 12th hour after crossover)
Title
BP
Description
Blood pressure (Includes systolic and diastolic blood pressure)
Time Frame
On the 48th hour after enrollment (On the 24th hour after crossover)
Title
BP
Description
Blood pressure (Includes systolic and diastolic blood pressure)
Time Frame
On the third day after enrollment (On the 48th hour after crossover)
Title
BP
Description
Blood pressure (Includes systolic and diastolic blood pressure)
Time Frame
On the 4th day after enrollment (On the third day after crossover)
Title
BP
Description
Blood pressure (Includes systolic and diastolic blood pressure)
Time Frame
On the 5th day after enrollment (On the 4th day after crossover)
Title
BP
Description
Blood pressure (Includes systolic and diastolic blood pressure)
Time Frame
On the 6th day after enrollment (On the 5th day after crossover)
Title
BP
Description
Blood pressure (Includes systolic and diastolic blood pressure)
Time Frame
On the 7th day after enrollment (On the 6th day after crossover)
Title
BP
Description
Blood pressure (Includes systolic and diastolic blood pressure)
Time Frame
On the 8th day after enrollment (On the 7th day after crossover)
Title
BP
Description
Blood pressure (Includes systolic and diastolic blood pressure)
Time Frame
On the 9th day after enrollment (On the 8th day after crossover)
Title
SO2
Description
Pulse oxygen saturation
Time Frame
At the time of enrollment in the clinical study
Title
SO2
Description
Pulse oxygen saturation
Time Frame
On the first hour after enrollment
Title
SO2
Description
Pulse oxygen saturation
Time Frame
On the second hour after enrollment
Title
SO2
Description
Pulse oxygen saturation
Time Frame
On the 6th hour after enrollment
Title
SO2
Description
Pulse oxygen saturation
Time Frame
On the 12th hour after enrollment
Title
SO2
Description
Pulse oxygen saturation
Time Frame
On the 24th hour after enrollment
Title
SO2
Description
Pulse oxygen saturation
Time Frame
On the 25th hour after enrollment (On the first hour after crossover)
Title
SO2
Description
Pulse oxygen saturation
Time Frame
On the 26th hour after enrollment (On the second hour after crossover)
Title
SO2
Description
Pulse oxygen saturation
Time Frame
On the 30th hour after enrollment (On the 6th hour after crossover)
Title
SO2
Description
Pulse oxygen saturation
Time Frame
On the 36th hour after enrollment (On the 12th hour after crossover)
Title
SO2
Description
Pulse oxygen saturation
Time Frame
On the 48th hour after enrollment (On the 24th hour after crossover)
Title
SO2
Description
Pulse oxygen saturation
Time Frame
On the third day after enrollment (On the 48th hour after crossover)
Title
SO2
Description
Pulse oxygen saturation
Time Frame
On the 4th day after enrollment (On the third day after crossover)
Title
SO2
Description
Pulse oxygen saturation
Time Frame
On the 5th day after enrollment (On the 4th day after crossover)
Title
SO2
Description
Pulse oxygen saturation
Time Frame
On the 6th day after enrollment (On the 5th day after crossover)
Title
SO2
Description
Pulse oxygen saturation
Time Frame
On the 7th day after enrollment (On the 6th day after crossover)
Title
SO2
Description
Pulse oxygen saturation
Time Frame
On the 8th day after enrollment (On the 7th day after crossover)
Title
SO2
Description
Pulse oxygen saturation
Time Frame
On the 9th day after enrollment (On the 8th day after crossover)
Title
pH
Description
Degree of pH in arterial blood
Time Frame
At the time of enrollment in the clinical study
Title
pH
Description
Degree of pH in arterial blood
Time Frame
On the 24th hour after enrollment
Title
pH
Description
Degree of pH in arterial blood
Time Frame
On the 48th hour after enrollment (On the 24th hour after crossover)
Title
pH
Description
Degree of pH in arterial blood
Time Frame
On the third day after enrollment (On the 48th hour after crossover)
Title
pH
Description
Degree of pH in arterial blood
Time Frame
On the 4th day after enrollment (On the 3th day after crossover)
Title
pH
Description
Degree of pH in arterial blood
Time Frame
On the 5th day after enrollment (On the 4th day after crossover)
Title
pH
Description
Degree of pH in arterial blood
Time Frame
On the 6th day after enrollment (On the 5th day after crossover)
Title
pH
Description
Degree of pH in arterial blood
Time Frame
On the 7th day after enrollment (On the 6th day after crossover)
Title
pH
Description
Degree of pH in arterial blood
Time Frame
On the 8th day after enrollment (On the 7th day after crossover)
Title
pH
Description
Degree of pH in arterial blood
Time Frame
On the 9th day after enrollment (On the 8th day after crossover)
Title
PaO2
Description
Partial arterial oxygen pressure
Time Frame
At the time of enrollment in the clinical study
Title
PaO2
Description
Partial arterial oxygen pressure
Time Frame
On the 24th hour after enrollment
Title
PaO2
Description
Partial arterial oxygen pressure
Time Frame
On the 48th hour after enrollment (On the 24th hour after crossover)
Title
PaO2
Description
Partial arterial oxygen pressure
Time Frame
On the third day after enrollment (On the 48th hour after crossover)
Title
PaO2
Description
Partial arterial oxygen pressure
Time Frame
On the 4th day after enrollment (On the 3th day after crossover)
Title
PaO2
Description
Partial arterial oxygen pressure
Time Frame
On the 5th day after enrollment (On the 4th day after crossover)
Title
PaO2
Description
Partial arterial oxygen pressure
Time Frame
On the 6th day after enrollment (On the 5th day after crossover)
Title
PaO2
Description
Partial arterial oxygen pressure
Time Frame
On the 7th day after enrollment (On the 6th day after crossover)
Title
PaO2
Description
Partial arterial oxygen pressure
Time Frame
On the 8th day after enrollment (On the 7th day after crossover)
Title
PaO2
Description
Partial arterial oxygen pressure
Time Frame
On the 9th day after enrollment (On the 8th day after crossover)
Title
SaO2
Description
Arterial oxygen saturation
Time Frame
At the time of enrollment in the clinical study
Title
SaO2
Description
Arterial oxygen saturation
Time Frame
On the 24th hour after enrollment
Title
SaO2
Description
Arterial oxygen saturation
Time Frame
On the 48th hour after enrollment (On the 24th hour after crossover)
Title
SaO2
Description
Arterial oxygen saturation
Time Frame
On the third day after enrollment (On the 48th hour after crossover)
Title
SaO2
Description
Arterial oxygen saturation
Time Frame
On the 4th day after enrollment (On the third day after crossover)
Title
SaO2
Description
Arterial oxygen saturation
Time Frame
On the 5th day after enrollment (On the 4th day after crossover)
Title
SaO2
Description
Arterial oxygen saturation
Time Frame
On the 6th day after enrollment (On the 5th day after crossover)
Title
SaO2
Description
Arterial oxygen saturation
Time Frame
On the 7th day after enrollment (On the 6th day after crossover)
Title
SaO2
Description
Arterial oxygen saturation
Time Frame
On the 8th day after enrollment (On the 7th day after crossover)
Title
SaO2
Description
Arterial oxygen saturation
Time Frame
On the 9th day after enrollment (On the 8th day after crossover)
Title
PCO2
Description
partial pressure of carbon dioxide in arterial blood
Time Frame
At the time of enrollment in the clinical study
Title
PCO2
Description
partial pressure of carbon dioxide in arterial blood
Time Frame
On the 24th hour after enrollment
Title
PCO2
Description
partial pressure of carbon dioxide in arterial blood
Time Frame
On the 48th hour after enrollment (On the 24th hour after crossover)
Title
PCO2
Description
partial pressure of carbon dioxide in arterial blood
Time Frame
On the third day after enrollment (On the 48th hour after crossover)
Title
PCO2
Description
partial pressure of carbon dioxide in arterial blood
Time Frame
On the 4th day after enrollment (On the third day after crossover)
Title
PCO2
Description
partial pressure of carbon dioxide in arterial blood
Time Frame
On the 5th day after enrollment (On the 4th day after crossover)
Title
PCO2
Description
partial pressure of carbon dioxide in arterial blood
Time Frame
On the 6th day after enrollment (On the 5th day after crossover)
Title
PCO2
Description
partial pressure of carbon dioxide in arterial blood
Time Frame
On the 7th day after enrollment (On the 6th day after crossover)
Title
PCO2
Description
partial pressure of carbon dioxide in arterial blood
Time Frame
On the 8th day after enrollment (On the 7th day after crossover)
Title
PCO2
Description
partial pressure of carbon dioxide in arterial blood
Time Frame
On the 9th day after enrollment (On the 8th day after crossover)
Title
FiO2
Description
Fraction of inspiration O2
Time Frame
At the time of enrollment in the clinical study
Title
FiO2
Description
Fraction of inspiration O2
Time Frame
On the 24th hour after enrollment
Title
FiO2
Description
Fraction of inspiration O2
Time Frame
On the 48th hour after enrollment (On the 24th hour after crossover)
Title
FiO2
Description
Fraction of inspiration O2
Time Frame
On the third day after enrollment (On the 48th hour after crossover)
Title
FiO2
Description
Fraction of inspiration O2
Time Frame
On the 4th day after enrollment (On the third day after crossover)
Title
FiO2
Description
Fraction of inspiration O2
Time Frame
On the 5th day after enrollment (On the 4th day after crossover)
Title
FiO2
Description
Fraction of inspiration O2
Time Frame
On the 6th day after enrollment (On the 5th day after crossover)
Title
FiO2
Description
Fraction of inspiration O2
Time Frame
On the 7th day after enrollment (On the 6th day after crossover)
Title
FiO2
Description
Fraction of inspiration O2
Time Frame
On the 8th day after enrollment (On the 7th day after crossover)
Title
FiO2
Description
Fraction of inspiration O2
Time Frame
On the 9th day after enrollment (On the 8th day after crossover)
Title
Lac
Description
Lactic acid in arterial blood
Time Frame
At the time of enrollment in the clinical study
Title
Lac
Description
Lactic acid in arterial blood
Time Frame
On the 24th hour after enrollment
Title
Lac
Description
Lactic acid in arterial blood
Time Frame
On the 48th hour after enrollment (On the 24th hour after crossover)
Title
Lac
Description
Lactic acid in arterial blood
Time Frame
On the third day after enrollment (On the 48th hour after crossover)
Title
Lac
Description
Lactic acid in arterial blood
Time Frame
On the 4th day after enrollment (On the third day after crossover)
Title
Lac
Description
Lactic acid in arterial blood
Time Frame
On the 5th day after enrollment (On the 4th day after crossover)
Title
Lac
Description
Lactic acid in arterial blood
Time Frame
On the 6th day after enrollment (On the 5th day after crossover)
Title
Lac
Description
Lactic acid in arterial blood
Time Frame
On the 7th day after enrollment (On the 6th day after crossover)
Title
Lac
Description
Lactic acid in arterial blood
Time Frame
On the 8th day after enrollment (On the 7th day after crossover)
Title
Lac
Description
Lactic acid in arterial blood
Time Frame
On the 9th day after enrollment (On the 8th day after crossover)
Title
Glu
Description
Arterial blood glucose in arterial blood
Time Frame
At the time of enrollment in the clinical study
Title
Glu
Description
Arterial blood glucose in arterial blood
Time Frame
On the 24th hour after enrollment
Title
Glu
Description
Arterial blood glucose in arterial blood
Time Frame
On the 48th hour after enrollment (On the 24th hour after crossover)
Title
Glu
Description
Arterial blood glucose in arterial blood
Time Frame
On the third day after enrollment (On the 48th hour after crossover)
Title
GLu
Description
Arterial blood glucose in arterial blood
Time Frame
On the 4th day after enrollment (On the third day after crossover)
Title
Glu
Description
Arterial blood glucose in arterial blood
Time Frame
On the 5th day after enrollment (On the 4th day after crossover)
Title
Glu
Description
Arterial blood glucose in arterial blood
Time Frame
On the 6th day after enrollment (On the 5th day after crossover)
Title
Glu
Description
Arterial blood glucose in arterial blood
Time Frame
On the 7th day after enrollment (On the 6th day after crossover)
Title
Glu
Description
Arterial blood glucose in arterial blood
Time Frame
On the 8th day after enrollment (On the 7th day after crossover)
Title
Glu
Description
Arterial blood glucose in arterial blood
Time Frame
On the 9th day after enrollment (On the 8th day after crossover)
Title
A-aDO2
Description
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
Time Frame
At the time of enrollment in the clinical study
Title
A-aDO2
Description
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
Time Frame
On the 24th hour after enrollment
Title
A-aDO2
Description
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
Time Frame
On the 48th hour after enrollment (On the 24th hour after crossover)
Title
A-aDO2
Description
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
Time Frame
On the third day after enrollment (On the 48th hour after crossover)
Title
A-aDO2
Description
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
Time Frame
On the 4th day after enrollment (On the third day after crossover)
Title
A-aDO2
Description
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
Time Frame
On the 5th day after enrollment (On the 4th day after crossover)
Title
A-aDO2
Description
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
Time Frame
On the 6th day after enrollment (On the 5th day after crossover)
Title
A-aDO2
Description
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
Time Frame
On the 7th day after enrollment (On the 6th day after crossover)
Title
A-aDO2
Description
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
Time Frame
On the 8th day after enrollment (On the 7th day after crossover)
Title
A-aDO2
Description
The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood
Time Frame
On the 9th day after enrollment (On the 8th day after crossover)
Title
BE
Description
Base excess in arterial blood
Time Frame
At the time of enrollment in the clinical study
Title
BE
Description
Base excess in arterial blood
Time Frame
On the 24th hour after enrollment
Title
BE
Description
Base excess in arterial blood
Time Frame
On the 48th hour after enrollment (On the 24th hour after crossover)
Title
BE
Description
Base excess in arterial blood
Time Frame
On the third day after enrollment (On the 48th hour after crossover)
Title
BE
Description
Base excess in arterial blood
Time Frame
On the 4th day after enrollment (On the third day after crossover)
Title
BE
Description
Base excess in arterial blood
Time Frame
On the 5th day after enrollment (On the 4th day after crossover)
Title
BE
Description
Base excess in arterial blood
Time Frame
On the 6th day after enrollment (On the 5th day after crossover)
Title
BE
Description
Base excess in arterial blood
Time Frame
On the 7th day after enrollment (On the 6th day after crossover)
Title
BE
Description
Base excess in arterial blood
Time Frame
On the 8th day after enrollment (On the 7th day after crossover)
Title
BE
Description
Base excess in arterial blood
Time Frame
On the 9th day after enrollment (On the 8th day after crossover)
Title
RI
Description
Respiratory Index
Time Frame
At the time of enrollment in the clinical study
Title
RI
Description
Respiratory Index
Time Frame
On the 24th hour after enrollment
Title
RI
Description
Respiratory Index
Time Frame
On the 48th hour after enrollment (On the 24th hour after crossover)
Title
RI
Description
Respiratory Index
Time Frame
On the third day after enrollment (On the 48th hour after crossover)
Title
RI
Description
Respiratory Index
Time Frame
On the 4th day after enrollment (On the third day after crossover)
Title
RI
Description
Respiratory Index
Time Frame
On the 5th day after enrollment (On the 4th day after crossover)
Title
RI
Description
Respiratory Index
Time Frame
On the 6th day after enrollment (On the 5th day after crossover)
Title
RI
Description
Respiratory Index
Time Frame
On the 7th day after enrollment (On the 6th day after crossover)
Title
RI
Description
Respiratory Index
Time Frame
On the 8th day after enrollment (On the 7th day after crossover)
Title
RI
Description
Respiratory Index
Time Frame
On the 9th day after enrollment (On the 8th day after crossover)
Title
Arterial blood HCO3- concentration
Description
Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration
Time Frame
At the time of enrollment in the clinical study
Title
Arterial blood HCO3- concentration
Description
Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration
Time Frame
On the 24th hour after enrollment
Title
Arterial blood HCO3- concentration
Description
Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration
Time Frame
On the 48th hour after enrollment (On the 24th hour after crossover)
Title
Arterial blood HCO3- concentration
Description
Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration
Time Frame
On the third day after enrollment (On the 48th hour after crossover)
Title
Arterial blood HCO3- concentration
Description
Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration
Time Frame
On the 4th day after enrollment (On the third day after crossover)
Title
Arterial blood HCO3- concentration
Description
Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration
Time Frame
On the 5th day after enrollment (On the 4th day after crossover)
Title
Arterial blood HCO3- concentration
Description
Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration
Time Frame
On the 6th day after enrollment (On the 5th day after crossover)
Title
Arterial blood HCO3- concentration
Description
Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration
Time Frame
On the 7th day after enrollment (On the 6th day after crossover)
Title
Arterial blood HCO3- concentration
Description
Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration
Time Frame
On the 8th day after enrollment (On the 7th day after crossover)
Title
Arterial blood HCO3- concentration
Description
Arterial blood HCO3- concentration,including arterial blood HCO3- std concentration
Time Frame
On the 9th day after enrollment (On the 8th day after crossover)
Title
Arterial blood K+ concentration
Description
Arterial blood K+ concentration
Time Frame
At the time of enrollment in the clinical study
Title
Arterial blood K+ concentration
Description
Arterial blood K+ concentration
Time Frame
On the 24th hour after enrollment
Title
Arterial blood K+ concentration
Description
Arterial blood K+ concentration
Time Frame
On the 48th hour after enrollment (On the 24th hour after crossover)
Title
Arterial blood K+ concentration
Description
Arterial blood K+ concentration
Time Frame
On the third day after enrollment (On the 48th hour after crossover)
Title
Arterial blood K+ concentration
Description
Arterial blood K+ concentration
Time Frame
On the 4th day after enrollment (On the third day after crossover)
Title
Arterial blood K+ concentration
Description
Arterial blood K+ concentration
Time Frame
On the 5th day after enrollment (On the 4th day after crossover)
Title
Arterial blood K+ concentration
Description
Arterial blood K+ concentration
Time Frame
On the 6th day after enrollment (On the 5th day after crossover)
Title
Arterial blood K+ concentration
Description
Arterial blood K+ concentration
Time Frame
On the 7th day after enrollment (On the 6th day after crossover)
Title
Arterial blood K+ concentration
Description
Arterial blood K+ concentration
Time Frame
On the 8th day after enrollment (On the 7th day after crossover)
Title
Arterial blood K+ concentration
Description
Arterial blood K+ concentration
Time Frame
On the 9th day after enrollment (On the 8th day after crossover)
Title
Arterial blood Ca2+ concentration
Description
Arterial blood Ca2+ concentration
Time Frame
At the time of enrollment in the clinical study
Title
Arterial blood Ca2+ concentration
Description
Arterial blood Ca2+ concentration
Time Frame
On the 24th hour after enrollment
Title
Arterial blood Ca2+ concentration
Description
Arterial blood Ca2+ concentration
Time Frame
On the 48th hour after enrollment (On the 24th hour after crossover)
Title
Arterial blood Ca2+ concentration
Description
Arterial blood Ca2+ concentration
Time Frame
On the third day after enrollment (On the 48th hour after crossover)
Title
Arterial blood Ca2+ concentration
Description
Arterial blood Ca2+ concentration
Time Frame
On the 4th day after enrollment (On the third day after crossover)
Title
Arterial blood Ca2+ concentration
Description
Arterial blood Ca2+ concentration
Time Frame
On the 5th day after enrollment (On the 4th day after crossover)
Title
Arterial blood Ca2+ concentration
Description
Arterial blood Ca2+ concentration
Time Frame
On the 6th day after enrollment (On the 5th day after crossover)
Title
Arterial blood Ca2+ concentration
Description
Arterial blood Ca2+ concentration
Time Frame
On the 7th day after enrollment (On the 6th day after crossover)
Title
Arterial blood Ca2+ concentration
Description
Arterial blood Ca2+ concentration
Time Frame
On the 8th day after enrollment (On the 7th day after crossover)
Title
Arterial blood Ca2+ concentration
Description
Arterial blood Ca2+ concentration
Time Frame
On the 9th day after enrollment (On the 8th day after crossover)
Title
Arterial blood Na+ concentration
Description
Arterial blood Na+ concentration
Time Frame
At the time of enrollment in the clinical study
Title
Arterial blood Na+ concentration
Description
Arterial blood Na+ concentration
Time Frame
On the 24th hour after enrollment
Title
Arterial blood Na+ concentration
Description
Arterial blood Na+ concentration
Time Frame
On the 48th hour after enrollment (On the 24th hour after crossover)
Title
Arterial blood Na+ concentration
Description
Arterial blood Na+ concentration
Time Frame
On the third day after enrollment (On the 48th hour after crossover)
Title
Arterial blood Na+ concentration
Description
Arterial blood Na+ concentration
Time Frame
On the 4th day after enrollment (On the third day after crossover)
Title
Arterial blood Na+ concentration
Description
Arterial blood Na+ concentration
Time Frame
On the 5th day after enrollment (On the 4th day after crossover)
Title
Arterial blood Na+ concentration
Description
Arterial blood Na+ concentration
Time Frame
On the 6th day after enrollment (On the 5th day after crossover)
Title
Arterial blood Na+ concentration
Description
Arterial blood Na+ concentration
Time Frame
On the 7th day after enrollment (On the 6th day after crossover)
Title
Arterial blood Na+ concentration
Description
Arterial blood Na+ concentration
Time Frame
On the 8th day after enrollment (On the 7th day after crossover)
Title
Arterial blood Na+ concentration
Description
Arterial blood Na+ concentration
Time Frame
On the 9th day after enrollment (On the 8th day after crossover)
Title
TCO2
Description
Total carbon dioxide in arterial blood
Time Frame
At the time of enrollment in the clinical study
Title
TCO2
Description
Total carbon dioxide in arterial blood
Time Frame
On the 24th hour after enrollment
Title
TCO2
Description
Total carbon dioxide in arterial blood
Time Frame
On the 48th hour after enrollment (On the 24th hour after crossover)
Title
TCO2
Description
Total carbon dioxide in arterial blood
Time Frame
On the third day after enrollment (On the 48th hour after crossover)
Title
TCO2
Description
Total carbon dioxide in arterial blood
Time Frame
On the 4th day after enrollment (On the third day after crossover)
Title
TCO2
Description
Total carbon dioxide in arterial blood
Time Frame
On the 5th day after enrollment (On the 4th day after crossover)
Title
TCO2
Description
Total carbon dioxide in arterial blood
Time Frame
On the 6th day after enrollment (On the 5th day after crossover)
Title
TCO2
Description
Total carbon dioxide in arterial blood
Time Frame
On the 7th day after enrollment (On the 6th day after crossover)
Title
TCO2
Description
Total carbon dioxide in arterial blood
Time Frame
On the 8th day after enrollment (On the 7th day after crossover)
Title
TCO2
Description
Total carbon dioxide in arterial blood
Time Frame
On the 9th day after enrollment (On the 8th day after crossover)
Title
HCT
Description
hematocrit in arterial blood
Time Frame
At the time of enrollment in the clinical study
Title
HCT
Description
hematocrit in arterial blood
Time Frame
On the 24th hour after enrollment
Title
HCT
Description
hematocrit in arterial blood
Time Frame
On the 48th hour after enrollment (On the 24th hour after crossover)
Title
HCT
Description
hematocrit in arterial blood
Time Frame
On the third day after enrollment (On the 48th hour after crossover)
Title
HCT
Description
hematocrit in arterial blood
Time Frame
On the 4th day after enrollment (On the third day after crossover)
Title
HCT
Description
hematocrit in arterial blood
Time Frame
On the 5th day after enrollment (On the 4th day after crossover)
Title
HCT
Description
hematocrit in arterial blood
Time Frame
On the 6th day after enrollment (On the 5th day after crossover)
Title
HCT
Description
hematocrit in arterial blood
Time Frame
On the 7th day after enrollment (On the 6th day after crossover)
Title
HCT
Description
hematocrit in arterial blood
Time Frame
On the 8th day after enrollment (On the 7th day after crossover)
Title
HCT
Description
hematocrit in arterial blood
Time Frame
On the 9th day after enrollment (On the 8th day after crossover)
Title
tHbc
Description
Total hemoglobin in arterial blood
Time Frame
At the time of enrollment in the clinical study
Title
tHbc
Description
Total hemoglobin in arterial blood
Time Frame
On the 24th hour after enrollment
Title
tHbc
Description
Total hemoglobin in arterial blood
Time Frame
On the 48th hour after enrollment (On the 24th hour after crossover)
Title
tHbc
Description
Total hemoglobin in arterial blood
Time Frame
On the third day after enrollment (On the 48th hour after crossover)
Title
tHbc
Description
Total hemoglobin in arterial blood
Time Frame
On the 4th day after enrollment (On the third day after crossover)
Title
tHbc
Description
Total hemoglobin in arterial blood
Time Frame
On the 5th day after enrollment (On the 4th day after crossover)
Title
tHbc
Description
Total hemoglobin in arterial blood
Time Frame
On the 6th day after enrollment (On the 5th day after crossover)
Title
tHbc
Description
Total hemoglobin in arterial blood
Time Frame
On the 7th day after enrollment (On the 6th day after crossover)
Title
tHbc
Description
Total hemoglobin in arterial blood
Time Frame
On the 8th day after enrollment (On the 7th day after crossover)
Title
tHbc
Description
Total hemoglobin in arterial blood
Time Frame
On the 9th day after enrollment (On the 8th day after crossover)
Title
height
Description
m
Time Frame
At the time of enrollment in the clinical study
Title
Weight
Description
Kg
Time Frame
At the time of enrollment in the clinical study
Title
gender
Description
Male and female
Time Frame
At the time of enrollment in the clinical study
Title
age
Description
year
Time Frame
At the time of enrollment in the clinical study
Title
WBC
Description
The number of white blood cells in venous blood
Time Frame
On the first day after enrollment
Title
WBC
Description
The number of white blood cells in venous blood
Time Frame
up to 9 days
Title
NEU
Description
The number of Neutrophil granulocyte in venous blood
Time Frame
On the first day after enrollment
Title
NEU
Description
The number of Neutrophil granulocyte in venous blood
Time Frame
up to 9 days
Title
LYM
Description
The number of Venous blood lymphocytes in venous blood
Time Frame
On the first day after enrollment
Title
LYM
Description
The number of Venous blood lymphocytes in venous blood
Time Frame
up to 9 days
Title
EOS
Description
The number of Venous blood eosinophils in venous blood
Time Frame
On the first day after enrollment
Title
EOS
Description
The number of Venous blood eosinophils in venous blood
Time Frame
up to 9 days
Title
BAS
Description
The number of Venous blood Basophils in venous blood
Time Frame
On the first day after enrollment
Title
BAS
Description
The number of Venous blood Basophils in venous blood
Time Frame
up to 9 days
Title
MON
Description
The number of Venous blood Monocyte cell in venous blood
Time Frame
On the first day after enrollment
Title
MON
Description
The number of Venous blood Monocyte cell in venous blood
Time Frame
up to 9 days
Title
RBC
Description
The number of red blood cells in venous blood
Time Frame
On the first day after enrollment
Title
RBC
Description
The number of red blood cells in venous blood
Time Frame
up to 9 days
Title
HGB
Description
The number of haemoglobin in venous blood
Time Frame
On the first day after enrollment
Title
HGB
Description
The number of haemoglobin in venous blood
Time Frame
up to 9 days
Title
HCT
Description
hematocrit in venous blood
Time Frame
On the first day after enrollment
Title
HCT
Description
hematocrit in venous blood
Time Frame
up to 9 days
Title
MCV
Description
Mean Corpuscular Volume in venous blood
Time Frame
On the first day after enrollment
Title
MCV
Description
Mean Corpuscular Volume in venous blood
Time Frame
up to 9 days
Title
MCH
Description
Mean Corpuscular Haemoglobin Concentration in venous blood
Time Frame
On the first day after enrollment
Title
MCH
Description
Mean Corpuscular Haemoglobin Concentration in venous blood
Time Frame
up to 9 days
Title
RDW
Description
red blood cell distribution width in venous blood
Time Frame
On the first day after enrollment
Title
RDW
Description
red blood cell distribution width in venous blood
Time Frame
up to 9 days
Title
PLT
Description
platelet in venous blood
Time Frame
On the first day after enrollment
Title
PLT
Description
platelet in venous blood
Time Frame
up to 9 days
Title
PDW
Description
Platelet distributionwidth in venous blood
Time Frame
On the first day after enrollment
Title
PDW
Description
Platelet distributionwidth in venous blood
Time Frame
up to 9 days
Title
MPV
Description
Mean Platelet Volume in venous blood
Time Frame
On the first day after enrollment
Title
MPV
Description
Mean Platelet Volume in venous blood
Time Frame
up to 9 days
Title
plateletcrit
Description
plateletcrit in venous blood
Time Frame
On the first day after enrollment
Title
plateletcrit
Description
plateletcrit in venous blood
Time Frame
up to 9 days
Title
CRP
Description
C-reactive protein in venous blood
Time Frame
On the first day after enrollment
Title
CRP
Description
C-reactive protein in venous blood
Time Frame
up to 9 days
Title
PCT
Description
Procalcitonin in venous blood
Time Frame
On the first day after enrollment
Title
PCT
Description
Procalcitonin in venous blood
Time Frame
up to 9 days
Title
NT-proBNP
Description
NT-proBNP in venous blood
Time Frame
On the first day after enrollment
Title
NT-proBNP
Description
NT-proBNP in venous blood
Time Frame
up to 9 days
Title
ESR
Description
erythrocytesedimentationrate in venous blood
Time Frame
On the first day after enrollment
Title
ESR
Description
erythrocytesedimentationrate in venous blood
Time Frame
up to 9 days
Title
PT
Description
prothrombin time in venous blood
Time Frame
On the first day after enrollment
Title
PT
Description
prothrombin time in venous blood
Time Frame
up to 9 days
Title
APTT
Description
activated partial thromboplastin time in venous blood
Time Frame
On the first day after enrollment
Title
APTT
Description
activated partial thromboplastin time in venous blood
Time Frame
up to 9 days
Title
TT
Description
Thrombin time in venous blood
Time Frame
On the first day after enrollment
Title
TT
Description
Thrombin time in venous blood
Time Frame
up to 9 days
Title
D-Di
Description
D-Dimer in venous blood
Time Frame
On the first day after enrollment
Title
D-Di
Description
D-Dimer in venous blood
Time Frame
up to 9 days
Title
ALT
Description
alanine transaminase in venous blood
Time Frame
On the first day after enrollment
Title
ALT
Description
alanine transaminase in venous blood
Time Frame
up to 9 days
Title
AST
Description
Aspartate Transaminase in venous blood
Time Frame
On the first day after enrollment
Title
AST
Description
Aspartate Transaminase in venous blood
Time Frame
up to 9 days
Title
PA
Description
Serum prealbumin in venous blood
Time Frame
On the first day after enrollment
Title
PA
Description
Serum prealbumin in venous blood
Time Frame
up to 9 days
Title
TP
Description
Total serum protein in venous blood
Time Frame
On the first day after enrollment
Title
TP
Description
Total serum protein in venous blood
Time Frame
up to 9 days
Title
ALB
Description
Albumin protein in venous blood
Time Frame
On the first day after enrollment
Title
ALB
Description
Albumin protein in venous blood
Time Frame
up to 9 days
Title
GLB
Description
Globulin globulin in venous blood
Time Frame
On the first day after enrollment
Title
GLB
Description
Globulin globulin in venous blood
Time Frame
up to 9 days
Title
Cr
Description
creatinine in venous blood
Time Frame
On the first day after enrollment
Title
Cr
Description
creatinine in venous blood
Time Frame
up to 9 days
Title
BUN
Description
Urea nitrogen in venous blood
Time Frame
On the first day after enrollment
Title
BUN
Description
Urea nitrogen in venous blood
Time Frame
up to 9 days
Title
Cys-C
Description
Cystatin C in venous blood
Time Frame
On the first day after enrollment
Title
Cys-C
Description
Cystatin C in venous blood
Time Frame
up to 9 days
Title
eGFR
Description
Estimate glomerular filtration rate in venous blood
Time Frame
On the first day after enrollment
Title
eGFR
Description
Estimate glomerular filtration rate in venous blood
Time Frame
up to 9 days
Title
Respiratory support time
Description
Daily respiratory support time after patients were enrolled in the clinical study,h/Day
Time Frame
during hospitalization, approximately 9 days
Title
Relief time for dyspnea
Description
Remission time of dyspnea after intervention
Time Frame
during hospitalization, approximately 9 days
Title
Tracheal intubation
Description
Yes or No
Time Frame
during hospitalization, approximately 9 days
Title
Stay in the ICU
Description
Yes or No
Time Frame
during hospitalization, approximately 9 days
Title
Complications
Description
Facial injury, flatulence,Gastroesophageal reflux,Dry throat, sore throat,pneumothorax,Eye irritation discomfort,Low blood pressure.
Time Frame
during hospitalization, approximately 9 days
Title
Outcome of disease
Description
Get better, get worse, die
Time Frame
during hospitalization, approximately 9 days
Title
Total bilirubin
Description
Serum total bilirubin in venous blood
Time Frame
On the first day after enrollment
Title
Total bilirubin
Description
Serum total bilirubin in venous blood
Time Frame
up to 9 days
Title
DBIL
Description
Direct bilirubin in venous blood
Time Frame
On the first day after enrollment
Title
DBIL
Description
Direct bilirubin in venous blood
Time Frame
up to 9 days
Title
IBIL
Description
Indirect bilirubin in venous blood
Time Frame
On the first day after enrollment
Title
IBIL
Description
Indirect bilirubin in venous blood
Time Frame
up to 9 days
Title
Diaphragm mobility
Description
The patient is lying in a flat position. The convex array probe is placed at the junction of the anterior axillary line, midclavicular line, and rib margin (bilaterally), with the probe mark facing outward and downward for measurement.
Time Frame
At the time of enrollment in the clinical study
Title
Diaphragm mobility
Description
The patient is lying in a flat position. The convex array probe is placed at the junction of the anterior axillary line, midclavicular line, and rib margin (bilaterally), with the probe mark facing outward and downward for measurement.
Time Frame
On the 24th hour after enrollment
Title
Diaphragm mobility
Description
The patient is lying in a flat position. The convex array probe is placed at the junction of the anterior axillary line, midclavicular line, and rib margin (bilaterally), with the probe mark facing outward and downward for measurement.
Time Frame
On the 48th hour after enrollment (On the 24th hour after crossover)
Title
Diaphragm mobility
Description
The patient is lying in a flat position. The convex array probe is placed at the junction of the anterior axillary line, midclavicular line, and rib margin (bilaterally), with the probe mark facing outward and downward for measurement.
Time Frame
up to 9 days
Title
Diaphragm thickness
Description
Includes end-inspiratory diaphragm thickness and end-expiratory diaphragm thickness;The patient is lying flat on the bed. A linear array probe is placed in the mid-axillary line or between the anterior and mid-axillary lines between the eighth and tenth ribs, and measurements are taken.
Time Frame
At the time of enrollment in the clinical study
Title
Diaphragm thickness
Description
Includes end-inspiratory diaphragm thickness and end-expiratory diaphragm thickness;The patient is lying flat on the bed. A linear array probe is placed in the mid-axillary line or between the anterior and mid-axillary lines between the eighth and tenth ribs, and measurements are taken.
Time Frame
On the 24th hour after enrollment
Title
Diaphragm thickness
Description
Includes end-inspiratory diaphragm thickness and end-expiratory diaphragm thickness;The patient is lying flat on the bed. A linear array probe is placed in the mid-axillary line or between the anterior and mid-axillary lines between the eighth and tenth ribs, and measurements are taken.
Time Frame
On the 48th hour after enrollment (On the 24th hour after crossover)
Title
Diaphragm thickness
Description
Includes end-inspiratory diaphragm thickness and end-expiratory diaphragm thickness;The patient is lying flat on the bed. A linear array probe is placed in the mid-axillary line or between the anterior and mid-axillary lines between the eighth and tenth ribs, and measurements are taken.
Time Frame
up to 9 days
Secondary Outcome Measure Information:
Title
Patient compliance to the treatment
Description
Patients were managed for compliance with the treatment.Dependent judgment Complete dependence: patients actively cooperate with medical staff in treatment Partial dependence: in most cases, patients can cooperate with the treatment, and in a few cases, patients resist the treatment but receive treatment after being enlightened by the medical staff. Non-dependence: patients have strong resistance and resistance, so that they are unable to use ventilators or nasal high-flow humidification instruments.
Time Frame
during hospitalization, approximately 9 days
Title
Kolcaba Comfort Scale (GCQ) assessment assesses patient comfort
Description
Kolcaba's General Comfort Questionnaire (GCQ) is composed of 28 items from 4 dimensions: physiological, psychological, spiritual, socio-cultural and environmental. The modification Scale adopts 1 to 4Likert Scale, with 1 indicating strongly disagree and 4 indicating strongly agree. In the negative question, 1 means strongly agree and 4 means strongly disagree. A higher score indicates more comfort.
Time Frame
during hospitalization, approximately 9 days
Title
Dyspnea rating scale
Description
According to the degree of dyspnea and symptoms of the patient, the lowest score is 0, the highest score is 10.
Time Frame
during hospitalization, approximately 9 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: . PaO2 < 60mmHg, SpO2 < 92%(without oxygen inhalation); Mild to moderate type I respiratory failure (100 mmHg < PaO/Fi02≤300 mmHg); Exclusion Criteria: Missing primary outcome measures Terminal stage of various chronic diseases; The patient or family members do not agree to NIV or HFNI treatment; Severe type I respiratory failure (PaO2/Fi02≤100 mmHg) Ventilation dysfunction (pH<7.30) Contradictory breathing The patient abandons or terminates treatment, automatically discharges or transfers to another hospital; Serious diseases, such as organ function damage and sepsis;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dedong Ma, MD
Phone
18560082806
Email
ma@qiluhuxi.com
First Name & Middle Initial & Last Name or Official Title & Degree
chunwei He, master
Phone
17361616499
Email
hechw160814@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dedong Ma, MD
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dedong Ma, MD
Phone
18560082806
Email
ma@qiluhuxi.com
First Name & Middle Initial & Last Name & Degree
Chunwei He, MBBS
Phone
17361616499
Email
hechw160814@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28124736
Citation
Milesi C, Essouri S, Pouyau R, Liet JM, Afanetti M, Portefaix A, Baleine J, Durand S, Combes C, Douillard A, Cambonie G; Groupe Francophone de Reanimation et d'Urgences Pediatriques (GFRUP). High flow nasal cannula (HFNC) versus nasal continuous positive airway pressure (nCPAP) for the initial respiratory management of acute viral bronchiolitis in young infants: a multicenter randomized controlled trial (TRAMONTANE study). Intensive Care Med. 2017 Feb;43(2):209-216. doi: 10.1007/s00134-016-4617-8. Epub 2017 Jan 26.
Results Reference
result
PubMed Identifier
33661521
Citation
Lewis SR, Baker PE, Parker R, Smith AF. High-flow nasal cannulae for respiratory support in adult intensive care patients. Cochrane Database Syst Rev. 2021 Mar 4;3(3):CD010172. doi: 10.1002/14651858.CD010172.pub3.
Results Reference
result
PubMed Identifier
29886648
Citation
Chen BX, Ou Q, Pan MX. [A cross-sectional survey of treatment acceptance and influence factors in patients with obstructive sleep apnea]. Zhonghua Yi Xue Za Zhi. 2018 May 29;98(20):1578-1581. doi: 10.3760/cma.j.issn.0376-2491.2018.20.010. Chinese.
Results Reference
result

Learn more about this trial

Comparative Study on the Effectiveness, Comfort and Compliance of HFNC and Noninvasive Mechanical Ventilation BiPAP Mode in the Treatment of Hypoxemia Patients

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