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High Flow Nasal Oxygen Therapy in Perioperative Period of the Adult With Hypercapnic and Hypoxemic Respiratory Faliure

Primary Purpose

Acute Respiratory Failure With Hypercapnia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
standard low flow therapy
high flow nasal oxygen therapy
association of high flow nasal oxygen therapy and non invasive positive pressure ventilation
Sponsored by
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Failure With Hypercapnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Hypoxemic and no hypercapnic acute respiratory failure :
  • severe dyspnea at rest with a respiratory rate >25 breaths/min
  • PaO2/FiO2 <300
  • PaCO2 <45 mmHg,

Exclusion Criteria:

  • age <18 years
  • NPPV contraindications
  • past history of respiratory chronic disease (COPD, cystic fibrosis…)
  • cardiac pulmonary edema
  • Pre-defined intubation
  • other than respiratory organ failure : systolic pressure <90 mmHg,current treatment with epinephrine or norepinephrine, decreased level of consciousness ( Glasgow score ≤ 12)
  • profound aplasia (white cells count <1000/mm 3)

Sites / Locations

  • Ethics Committee of Xinhua HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

standard low flow therapy

high flow nasal oxygen therapy

Noninvasive ventilation

Arm Description

In the standard low flow therapy is applied continuously through a nonrebreather face mask at a flow rate of 10 liters per minute or more. The rate was adjusted to maintain an oxygen saturation level of 92% or more.

In the high-flow-oxygen group is passed through a heated humidifier and applied continuously through large-bore binasal prongs, with a gas flow rate of 30-60 liters per minute . The fraction of oxygen in the gas flowing in the system was subsequently adjusted to maintain an Spo2 of 92% or more.

In the noninvasive-ventilation group is delivered to the patient through a face mask that was connected to an ICU ventilator,with pressure support applied in a noninvasive ventilation mode. The Fio2 or PEEP level (or both) were then adjusted to maintain an Spo2 of 92% or more.

Outcomes

Primary Outcome Measures

the number of patients in each group who require endotracheal intubation with mechanical ventilation
To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation

Secondary Outcome Measures

mechanical ventilation-free to day 28

Full Information

First Posted
July 23, 2017
Last Updated
December 3, 2018
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03229460
Brief Title
High Flow Nasal Oxygen Therapy in Perioperative Period of the Adult With Hypercapnic and Hypoxemic Respiratory Faliure
Official Title
High Flow Nasal Oxygen Therapy in Perioperative Period of the Adult With Hypercapnic and Hypoxemic Respiratory Faliure
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2019 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the impact of hign-flow nasal therapy on the adult with hypercapnia and hpoxemia respiratory faliure in comparison with standard oxygen therapy ang noninvasive ventilation.
Detailed Description
Humidified high flow nasal oxygen therapy decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase.The purpose of this study is to determine the impact of hign-flow nasal therapy on adult hypercapnic respiratory failure by comparing with nasal continuous positive airway pressure

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure With Hypercapnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard low flow therapy
Arm Type
Active Comparator
Arm Description
In the standard low flow therapy is applied continuously through a nonrebreather face mask at a flow rate of 10 liters per minute or more. The rate was adjusted to maintain an oxygen saturation level of 92% or more.
Arm Title
high flow nasal oxygen therapy
Arm Type
Experimental
Arm Description
In the high-flow-oxygen group is passed through a heated humidifier and applied continuously through large-bore binasal prongs, with a gas flow rate of 30-60 liters per minute . The fraction of oxygen in the gas flowing in the system was subsequently adjusted to maintain an Spo2 of 92% or more.
Arm Title
Noninvasive ventilation
Arm Type
Placebo Comparator
Arm Description
In the noninvasive-ventilation group is delivered to the patient through a face mask that was connected to an ICU ventilator,with pressure support applied in a noninvasive ventilation mode. The Fio2 or PEEP level (or both) were then adjusted to maintain an Spo2 of 92% or more.
Intervention Type
Other
Intervention Name(s)
standard low flow therapy
Intervention Description
In the standard low flow therapy oxygen group, oxygen at a flow rate of 10 liters per minute or more.
Intervention Type
Device
Intervention Name(s)
high flow nasal oxygen therapy
Intervention Description
The patient will receive high flow nasal of humidified oxygen, set between 30 to 60 l/min. The inspired fraction of oxygen (FiO2) will be adjusted in order to obtain a SpO2 >92%.
Intervention Type
Device
Intervention Name(s)
association of high flow nasal oxygen therapy and non invasive positive pressure ventilation
Intervention Description
The patient will receive successively in a day NPPV and O2-HFN. The NPPV will be applied with an airway humidification achieved by using a heated humidifier and a facial mask adapted to the morphology of the patient. The settings will be adjusted as follow : an inspiratory pressure between 6 to 14 cmH2O, in order to obtain a tidal volume between 7 to 10 ml/kg of predicted weight, a positive expiratory pressure between 0 to 10 cmH2O in order to obtain a SpO2 >92% with the minimal FiO2.
Primary Outcome Measure Information:
Title
the number of patients in each group who require endotracheal intubation with mechanical ventilation
Description
To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation
Time Frame
28days
Secondary Outcome Measure Information:
Title
mechanical ventilation-free to day 28
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Hypoxemic and no hypercapnic acute respiratory failure : severe dyspnea at rest with a respiratory rate >25 breaths/min PaO2/FiO2 <300 PaCO2 <45 mmHg, Exclusion Criteria: age <18 years NPPV contraindications past history of respiratory chronic disease (COPD, cystic fibrosis…) cardiac pulmonary edema Pre-defined intubation other than respiratory organ failure : systolic pressure <90 mmHg,current treatment with epinephrine or norepinephrine, decreased level of consciousness ( Glasgow score ≤ 12) profound aplasia (white cells count <1000/mm 3)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
bin he
Phone
021-25077828
Email
hebinicu@139.com
First Name & Middle Initial & Last Name or Official Title & Degree
dongjuan tang
Email
317582862@qq.com
Facility Information:
Facility Name
Ethics Committee of Xinhua Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guangyu Chen, PhD
Phone
+86-02125076143
Email
xinhuacru@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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High Flow Nasal Oxygen Therapy in Perioperative Period of the Adult With Hypercapnic and Hypoxemic Respiratory Faliure

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