Effects of Respiratory Rehabilitation on ICU Patients

Effects of Respiratory Rehabilitation on Patients After Extubation

Effects of respiratory rehabilitation on patients after extubation

Study Overview

• Status: Unknown
• Conditions: Rehabilitation; ICU Acquired Weakness
• Intervention / Treatment: Behavioral: pulmonary rehabilitation

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ying zhao; Phone Number: +86 17600953801; Email: 1412888703@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rehabilitation group; To conduct a comprehensive pulmonary rehabilitation assessment and treatment	Behavioral: pulmonary rehabilitation; 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.
No Intervention: Conventional medical group; Conventional medical treatment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Investigators: Principal Investigator: xin li xie, Ph.D., Study Principal Investigator Chinese PLA General Hospital

Publications and helpful links

General Publications

• 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. Erratum In: JAMA. 2016 Nov 15;316(19):2047-2048. JAMA. 2017 Feb 28;317(8):858.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 20, 2020
• Primary Completion (Anticipated): April 20, 2021
• Study Completion (Anticipated): April 20, 2021

Study Registration Dates

• First Submitted: April 22, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): December 16, 2020
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: ICU，rehabilitation
• Other Study ID Numbers: S2018-212-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No