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

Not Applicable

• Conditions: Pulmonary Disease
• Interventions: Behavioral: Pulmonary rehabilitation therapy

• Registration Number: NCT04441151
• Lead Sponsor: Chinese PLA General Hospital

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.

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-06-16
• Study First Submitted QC: 2020-06-18
• Study First Posted: 2020-06-22
• Last Update Submitted: 2020-12-14
• Last Update Posted: 2020-12-16
• Study Start: 2020-12-20
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Pulmonary rehabilitation therapy	Pulmonary rehabilitation therapy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Intubation	Day 28	Intubation,Whether endotracheal intubation was performed for invasive mechanical ventilation within 28 days
Complication	Day 28	The incidence of new complications(pressure sores、thrombus、aspiration).
Hospitalization time	Month 3	Hospitalization time,length of stay in hospital.
The time it takes to get out of bed for the first time	Day 28	The time it takes to get out of bed for the first time
Use of non-invasive ventilator	Day 28	Use of non-invasive ventilator,Whether to use non-invasive ventilator within 28 days.
mortality	Day 28	mortality
ICU stay time	3 month	icu length of stay