Effects of Respiratory Rehabilitation on ICU Patients

Study Overview
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Brief Summary
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Effects of respiratory rehabilitation on patients after extubation

Detailed Description
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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.

Official Title
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Effects of Respiratory Rehabilitation on Patients After Extubation

Conditions
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ICU Acquired Weakness, Rehabilitation

Intervention / Treatment
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* Behavioral: pulmonary rehabilitation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rehabilitation group<br>To conduct a comprehensive pulmonary rehabilitation assessment and treatment | Behavioral: pulmonary rehabilitation<br>* Pulmonary rehabilitation (respiratory rehabilitation) is a comprehensive intervention based on a comprehensive patient assessment, targeted to the treatment of patients, including but not limited to exercise training, education and behavior change, aimed at improving the physical and mental health of patients with chronic respiratory diseases and promoting long-term adherence to health-enhancing behaviors.<br>|
| No Intervention: Conventional medical group<br>Conventional medical treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reintubation rates | The artificial airway was established again for invasive mechanical ventilation | 28 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICU，rehabilitation