Clinical trial NCT04441151: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Disease
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: MRC
timeFrame: Day 28
measure: STS
timeFrame: Day 28
measure: barthel index
timeFrame: Day 28
measure: Borg dyspnea score
timeFrame: Day 28
measure: PaO2
timeFrame: Day 28
measure: Oxygenation index
timeFrame: Day 28
measure: Diaphragm mobility
timeFrame: Day 28
measure: Diaphragm contraction velocity
timeFrame: Day 28
measure: End-inspiratory diaphragm thickness
timeFrame: Day 28
measure: End-expiratory diaphragm thickness
timeFrame: Day 28
measure: Diaphragm thickness variation rate
timeFrame: Day 28
Secondary outcomes:
measure: ICU stay time
timeFrame: 3 month
measure: Hospitalization time
timeFrame: Month 3
measure: The time it takes to get out of bed for the first time
timeFrame: Day 28
measure: Use of non-invasive ventilator
timeFrame: Day 28
measure: Intubation
timeFrame: Day 28
measure: mortality
timeFrame: Day 28
measure: Complication
timeFrame: Day 28
Other outcomes:
Locations:
Study officials:
affiliation: The First Medical Center of PLA General Hospital
name: Zhao Ying
role: PRINCIPAL_INVESTIGATOR
References: