Evaluation of the Effect of Pulmonary Rehabilitation on Patients With High Flow Oxygen Therapy
Primary Purpose
Pulmonary Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pulmonary rehabilitation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- The age is ≥ 18 years old;
- the hemodynamics is stable;
- 50 < heart rate < 120 beats / min ;
- 90 < systolic blood pressure < 200mmHg ;
- 55 < mean arterial pressure < 120mmHg;
- do not increase the dose of pressor drugs for at least 2 hours;
- intracranial pressure is stable and there are no seizures within 24 hours;
- the respiratory state is stable;
- the patient's finger pulse oxygen saturation ≥ 88%;
- 10 < respiratory frequency < 35 beats / min.
Exclusion Criteria:
- Pregnancy;
- acute cardio-cerebrovascular events;
- spinal or limb fractures;
- active bleeding.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
Pulmonary rehabilitation therapy
Routine medical treatment
Outcomes
Primary Outcome Measures
MRC
Medical Research Council,Muscle strength assessment,total points0~60,less than 48scores means ICU aquired weaknesses.
STS
Number of sit-to-stand test in 30s,Muscle endurance assessment,The more times, has the better muscular endurance.
barthel index
barthel index,Daily activity assessment,Assessment of activities of daily living.total points0~100,less than 60 scores means can't independent living.
Borg dyspnea score
Borg dyspnea score,Maximum 10 points,Minimum 0,The higher the score, the harder it is to breathe
PaO2
arterial partial pressure of oxygen,Partial pressure of oxygen in arterial blood,normal range is 80~100.
Oxygenation index
arterial partial pressure of oxygen divided by the oxygen concentration,Normal is greater than 400.
Diaphragm mobility
The distance the diaphragm drops during inhalation,normal is 1.4cm.
Diaphragm contraction velocity
The rate at which the diaphragm contracts during inhalation,normal is 1.3cm/s.
End-inspiratory diaphragm thickness
The thickness of the diaphragm during inhalation,The thickness of diaphragm at the end of expiratory is about 0.25cm.
End-expiratory diaphragm thickness
The thickness of the diaphragm during exhalation,The thickness of diaphragm at the end of expiratory is about 0.15cm.
Diaphragm thickness variation rate
Rate of diaphragmatic thickness change during breathing,Diaphragmatic dysfunction is considered less than 20%.
Secondary Outcome Measures
ICU stay time
icu length of stay
Hospitalization time
Hospitalization time,length of stay in hospital.
The time it takes to get out of bed for the first time
The time it takes to get out of bed for the first time
Use of non-invasive ventilator
Use of non-invasive ventilator,Whether to use non-invasive ventilator within 28 days.
Intubation
Intubation,Whether endotracheal intubation was performed for invasive mechanical ventilation within 28 days
mortality
mortality
Complication
The incidence of new complications(pressure sores、thrombus、aspiration).
Full Information
NCT ID
NCT04441151
First Posted
June 16, 2020
Last Updated
December 14, 2020
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04441151
Brief Title
Evaluation of the Effect of Pulmonary Rehabilitation on Patients With High Flow Oxygen Therapy
Official Title
Evaluation of the Effect of Pulmonary Rehabilitation on Patients With High Flow Oxygen Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 20, 2020 (Anticipated)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Evaluation of the effect of pulmonary rehabilitation on patients with high flow oxygen therapy
Detailed Description
Objective: the purpose of this study was to evaluate the effect of lung rehabilitation on patients treated with high flow humidification apparatus in ICU. Methods: 70 patients in ICU who were treated with high flow humidification apparatus from June 2019 to June 2020 were randomly divided into two groups. The experimental group was treated with pulmonary rehabilitation and the control group was treated with routine medical treatment only. All patients were evaluated and measured by bedside diaphragm ultrasound. The vital signs of all patients were monitored every day. MRCsum assessment of peripheral muscle strength, 30s sitting test, modified Barthel index, Borg dyspnea score, arterial blood gas analysis and bedside diaphragm ultrasound monitoring were performed at admission and discharge. Finally, statistics were made on the use of non-invasive ventilator, endotracheal intubation, new complications (pressure sore, aspiration, thrombus, etc.) and the time of patients getting out of bed for the first time.The end point of the experiment was 28 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Pulmonary rehabilitation therapy
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Routine medical treatment
Intervention Type
Behavioral
Intervention Name(s)
Pulmonary rehabilitation therapy
Intervention Description
Comprehensive interventions based on comprehensive evaluation and customization of patients, including, but not limited to, exercise training, education and behavioral changes, aimed at improving the physiological and psychological status of patients with chronic respiratory diseases, and urge patients to adhere to health promotion activities for a long time.
Primary Outcome Measure Information:
Title
MRC
Description
Medical Research Council,Muscle strength assessment,total points0~60,less than 48scores means ICU aquired weaknesses.
Time Frame
Day 28
Title
STS
Description
Number of sit-to-stand test in 30s,Muscle endurance assessment,The more times, has the better muscular endurance.
Time Frame
Day 28
Title
barthel index
Description
barthel index,Daily activity assessment,Assessment of activities of daily living.total points0~100,less than 60 scores means can't independent living.
Time Frame
Day 28
Title
Borg dyspnea score
Description
Borg dyspnea score,Maximum 10 points,Minimum 0,The higher the score, the harder it is to breathe
Time Frame
Day 28
Title
PaO2
Description
arterial partial pressure of oxygen,Partial pressure of oxygen in arterial blood,normal range is 80~100.
Time Frame
Day 28
Title
Oxygenation index
Description
arterial partial pressure of oxygen divided by the oxygen concentration,Normal is greater than 400.
Time Frame
Day 28
Title
Diaphragm mobility
Description
The distance the diaphragm drops during inhalation,normal is 1.4cm.
Time Frame
Day 28
Title
Diaphragm contraction velocity
Description
The rate at which the diaphragm contracts during inhalation,normal is 1.3cm/s.
Time Frame
Day 28
Title
End-inspiratory diaphragm thickness
Description
The thickness of the diaphragm during inhalation,The thickness of diaphragm at the end of expiratory is about 0.25cm.
Time Frame
Day 28
Title
End-expiratory diaphragm thickness
Description
The thickness of the diaphragm during exhalation,The thickness of diaphragm at the end of expiratory is about 0.15cm.
Time Frame
Day 28
Title
Diaphragm thickness variation rate
Description
Rate of diaphragmatic thickness change during breathing,Diaphragmatic dysfunction is considered less than 20%.
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
ICU stay time
Description
icu length of stay
Time Frame
3 month
Title
Hospitalization time
Description
Hospitalization time,length of stay in hospital.
Time Frame
Month 3
Title
The time it takes to get out of bed for the first time
Description
The time it takes to get out of bed for the first time
Time Frame
Day 28
Title
Use of non-invasive ventilator
Description
Use of non-invasive ventilator,Whether to use non-invasive ventilator within 28 days.
Time Frame
Day 28
Title
Intubation
Description
Intubation,Whether endotracheal intubation was performed for invasive mechanical ventilation within 28 days
Time Frame
Day 28
Title
mortality
Description
mortality
Time Frame
Day 28
Title
Complication
Description
The incidence of new complications(pressure sores、thrombus、aspiration).
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The age is ≥ 18 years old;
the hemodynamics is stable;
50 < heart rate < 120 beats / min ;
90 < systolic blood pressure < 200mmHg ;
55 < mean arterial pressure < 120mmHg;
do not increase the dose of pressor drugs for at least 2 hours;
intracranial pressure is stable and there are no seizures within 24 hours;
the respiratory state is stable;
the patient's finger pulse oxygen saturation ≥ 88%;
10 < respiratory frequency < 35 beats / min.
Exclusion Criteria:
Pregnancy;
acute cardio-cerebrovascular events;
spinal or limb fractures;
active bleeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhao Ying
Phone
17600953801
Ext
17600953801
Email
1412888703@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhao Ying
Organizational Affiliation
The First Medical Center of PLA General Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of the Effect of Pulmonary Rehabilitation on Patients With High Flow Oxygen Therapy
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