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Effects of Respiratory Rehabilitation on ICU Patients

NCT ID: NCT04368286

Last Updated: 2020-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-20

Study Completion Date

2021-04-20

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.

Conditions

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ICU Acquired Weakness Rehabilitation

Keywords

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ICU，rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Rehabilitation group

To conduct a comprehensive pulmonary rehabilitation assessment and treatment

Group Type EXPERIMENTAL

pulmonary rehabilitation

Intervention Type BEHAVIORAL

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.

Conventional medical group

Conventional medical treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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wang kaifei

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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xin li xie, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator Chinese PLA General Hospital

Countries

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China

Central Contacts

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ying zhao

Role: CONTACT

Phone: +86 17600953801

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 27706464 (View on PubMed)

Other Identifiers

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S2018-212-01

Identifier Type: -

Identifier Source: org_study_id