Evaluation of the Effect of Pulmonary Rehabilitation on Patients With High Flow Oxygen Therapy

Study Overview
=================
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.

Official Title
-----------------
Evaluation of the Effect of Pulmonary Rehabilitation on Patients With High Flow Oxygen Therapy

Conditions
-----------------
Pulmonary Disease

Intervention / Treatment
-----------------
* Behavioral: Pulmonary rehabilitation therapy


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Pulmonary rehabilitation therapy | Behavioral: Pulmonary rehabilitation therapy<br>* 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.<br>|
| No Intervention: Control group<br>Routine medical treatment | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRC | Medical Research Council,Muscle strength assessment,total points0 60，less than 48scores means ICU aquired weaknesses. | Day 28 | 
| STS | Number of sit-to-stand test in 30s,Muscle endurance assessment,The more times, has the better muscular endurance. | Day 28 | 
| 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. | Day 28 | 
| Borg dyspnea score | Borg dyspnea score,Maximum 10 points,Minimum 0,The higher the score, the harder it is to breathe | Day 28 | 
| PaO2 | arterial partial pressure of oxygen,Partial pressure of oxygen in arterial blood,normal range is 80 100. | Day 28 | 
| Oxygenation index | arterial partial pressure of oxygen divided by the oxygen concentration,Normal is greater than 400. | Day 28 | 
| Diaphragm mobility | The distance the diaphragm drops during inhalation,normal is 1.4cm. | Day 28 | 
| Diaphragm contraction velocity | The rate at which the diaphragm contracts during inhalation,normal is 1.3cm/s. | Day 28 | 
| End-inspiratory diaphragm thickness | The thickness of the diaphragm during inhalation,The thickness of diaphragm at the end of expiratory is about 0.25cm. | Day 28 | 
| End-expiratory diaphragm thickness | The thickness of the diaphragm during exhalation,The thickness of diaphragm at the end of expiratory is about 0.15cm. | Day 28 | 
| Diaphragm thickness variation rate | Rate of diaphragmatic thickness change during breathing,Diaphragmatic dysfunction is considered less than 20%. | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU stay time | icu length of stay | 3 month | 
| Hospitalization time | Hospitalization time,length of stay in hospital. | Month 3 | 
| 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 | Day 28 | 
| Use of non-invasive ventilator | Use of non-invasive ventilator,Whether to use non-invasive ventilator within 28 days. | Day 28 | 
| Intubation | Intubation,Whether endotracheal intubation was performed for invasive mechanical ventilation within 28 days | Day 28 | 
| mortality | mortality | Day 28 | 
| Complication | The incidence of new complications(pressure sores、thrombus、aspiration). | Day 28 |