Clinical trial NCT04368286: Effects of Respiratory Rehabilitation on ICU Patients
Official title: Effects of Respiratory Rehabilitation on Patients After Extubation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ICU Acquired Weakness
Rehabilitation
Keywords: ICU，rehabilitation
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Reintubation rates
timeFrame: 28 days
Secondary outcomes:
measure: MRC，medical research council
timeFrame: 28 days
measure: 30-STS
timeFrame: 28 days
measure: Barthel
timeFrame: 28 days
measure: Borg dyspnea score
timeFrame: 28 days
measure: oxygen partial pressure
timeFrame: 28 days
measure: oxygenation index
timeFrame: 28 days
measure: The diaphragmatic excursion
timeFrame: 28 days
measure: diaphragm contraction rate
timeFrame: 28 days
measure: diaphragm thickness diaphragm thickness fraction
timeFrame: 28 days
measure: length of stay in ICU
timeFrame: three months
measure: LOS(length of stay)
timeFrame: three months
measure: First time out of bed
timeFrame: three months
measure: Noninvasive utilization rate
timeFrame: 28 days
measure: mortality
timeFrame: 28 days
measure: Complication rate
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
affiliation: Study Principal Investigator Chinese PLA General Hospital
name: xin li xie, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hernandez G, Vaquero C, Colinas L, Cuena R, Gonzalez P, Canabal A, Sanchez S, Rodriguez ML, Villasclaras A, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1565-1574. doi: 10.1001/jama.2016.14194.