Effects of Respiratory Rehabilitation on ICU Patients

Not Applicable

• Conditions: ICU Acquired Weakness; Rehabilitation
• Interventions: Behavioral: pulmonary rehabilitation

• Registration Number: NCT04368286
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

Effects of respiratory rehabilitation on patients after extubation

Detailed Description

The purpose of this study is to evaluate whether sequential treatment with high-flow humidification therapy apparatus can improve the postoperative recovery and functional status of patients with invasive mechanical ventilation in ICU after the withdrawal of the catheter.Inclusion criteria: age 18-95;The hemodynamics were stable, that is, 50 \< heart rate less than 120 beats/min, 90 \< systolic blood pressure \< 200mmHg, 55 \< mean arterial pressure \< 120mmHg.Do not increase the dose of vasopressor for at least 2 hours;Intracranial pressure was stable and there was no seizure within 24 hours.The breathing condition was stable, that is, the oxygen satiety of the patient's finger vein was ≥88%, and the breathing frequency was \>10 and\< 35 times/min.Exclusion criteria: pregnancy;Acute myocardial infarction.A total of 50 patients who are sequentially treated with high-flow humidification therapy apparatus after extubation in ICU are randomly assigned. The experimental group receive respiratory rehabilitation therapy, while the control group only receive routine medical treatment. All the enrolled patients underwent rehabilitation evaluation and bedside diaphragmatic ultrasound measurement.This study was approved by the Ethics Committee of the CPLA General Hospital (project No.2018-212-01). The following clinical datas were recorded for all patients through the unified database software: The rehabilitation program was formulated according to the cluster management strategy of ABCDEF and the six-step method of early activities.All of the patients in monitoring vital signs, every day at hospital group and all peripheral muscle MRC assessment, 30 s sit stand trial, modified Barthel index, Borg dyspnea score, arterial blood gas analysis, diaphragm ultrasonic monitoring by the bed, finally the experimental process on the patients whether using noninvasive ventilator, whether for endotracheal intubation again, whether to have new complications (pressure sores, aspiration, thrombosis, etc.) and the patients bed time statistics for the first time. Statistical analyses were conducted by SPSS 21.0 and a two-tailed P \< 0.05 was considered significant.

Study Timeline

• Study First Submitted: 2020-04-22
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-29
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-14
• Last Update Posted: 2020-12-16
• Study Start: 2020-12-20
• Primary Completion: 2021-04-20
• Study Completion: 2021-04-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Aged above 18
• The hemodynamics are stable
• 50 < heart rate less than 120 beats/min
• 90 < systolic blood pressure < 200mmHg
• 55 < mean arterial pressure < 120mmHg
• Do not increase the dose of vasopressor for at least 2 hours
• Intracranial pressure was stable and there is no seizure within 24 hours
• The breathing condition is stable
• the oxygen satiety of the patient's finger vein is ≥88%
• 10<the breathing frequency < 35 times/min

Exclusion Criteria

• Pregnancy
• Acute myocardial infarction (ami)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rehabilitation group	pulmonary rehabilitation	To conduct a comprehensive pulmonary rehabilitation assessment and treatment

Primary Outcome Measures

Name	Time	Method
Reintubation rates	28 days	The artificial airway was established again for invasive mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
30-STS	28 days	30 second sit-to-stand test.The more times, has the better muscular endurance.
LOS(length of stay)	three months	length of stay in hospital
First time out of bed	three months	First time out of bed by oneself
The diaphragmatic excursion	28 days	The distance the diaphragm moves up and down during breathing,normal is 1.4cm.
mortality	28 days	Alive or Dead
MRC，medical research council	28 days	medical research council，Assessment of peripheral muscle strength，total points0\~60，less than 48scores means ICU aquired weaknesses.
diaphragm thickness diaphragm thickness fraction	28 days	Thickness of diaphragm during breathing,(Diaphragm thickness at the end of inhalation-Diaphragm thickness at the end of exhalation)/Diaphragm thickness at the end of exhalation
Barthel	28 days	Assessment of activities of daily living.total points0\~100，less than 60 scores means can't independent living.
oxygenation index	28 days	The partial pressure of oxygen divided by the concentration of oxygen,Normal is greater than 400.
length of stay in ICU	three months	Length of stay in ICU
Noninvasive utilization rate	28 days	Non-invasive ventilator usage
Borg dyspnea score	28 days	total points0\~10,The higher the grade, the more difficulty breathing.
diaphragm contraction rate	28 days	The rate at which the diaphragm contracts during breathing,normal is 1.3cm/s.
Complication rate	28 days	The incidence of new complications(pressure sores、thrombus、aspiration)
oxygen partial pressure	28 days	Partial pressure of oxygen in arterial blood,normal range is 80\~100.