The Implementation of Early Mobilization and Chest Physiotherapy on Weaning Rate of Prolong Weaning Patients.

October 18, 2023 updated by: Taoyuan General Hospital

The Implementation of Early Mobilization and Chest Physiotherapy on Weaning Rate of Prolong Weaning Patients. A Retrospective Study

Weaning from mechanical ventilator is essential to liberate patients to normal life. Prolong weaning is defined as failure of 3 times spontaneous breath trial (SBT) and requiring more than 7 days weaning from mechanical ventilation after first SBT. higher unsuccessful rate of extubation and higher mortality rate. Possible reasons to cause prolong weaning could be attributed to intensive care unit acquired weakness (ICU-AW) and poor lung hygiene. In order to solve these two problems and increase the weaning rate, early mobilization (EM) and chest physiotherapy (CPT) are considered as possible strategy to attain the goal. According to previous articles, lacking of control group and small sample size made it difficult to confirm the true effect of EM and CPT on prolong weaning patients. Thus, the aims of this articles are discussing the influence from EM with CPT on weaning rate and other hospitalization outcomes with larger sample sizes and control group.

Study Overview

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Taoyuan Dist.
      • Taoyuan, Taoyuan Dist., Taiwan, 330
        • Taoyaun General Hospital, Ministry of Wealth and Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The subjects' data which met the inclusion criteria are: 1. Age>20 2. Patient with or without 3. Patient who met the criteria of received physiotherapy (Figure 1.) 4. No usage of life support device such as ECMO and so on. 5. Continuous mechanical ventilator use over 21 days.

Exclusion Criteria:

  • The exclusion criteria are 1. Patients diagnosed as brain death 2. Patients who were ventilator dependent before admission 3. Patients who were against advice discharge under critical condition. 4. Patients received emergency intervention during course. 5. Patient who didn't meet the criteria of received physiotherapy (Figure 1.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early mobilization plus chest physiotherapy
Physiotherapy program comprised two parts early mobilization and CPT. They could be divided into different levels depended on patients' ability. In terms of the levels of early mobilization, first level was defined as patients who could only receive passive patterns of exercise. Second level would be executed to patient who could only take exercise on the bed or with back support. Third level would be implemented when patients could advance to receive physiotherapy beside the bed without support. The eventual level would be conducted when patients was able to leave beds by their own. In line with chest physiotherapy, level I was defined as patients who could only receive passive lung hygiene protocol. Level II would be executed when patient can control their breath and cough by their own. Level III would be implemented when patient can maintain their body steadily and finish the chest physiotherapy protocol.

Early mobilization:early mobilization has been confirmed its positive effectiveness on cutting down the MV use days and mortality rate, attenuating the side effect such as muscle strength loss and functional activity dysfunction resulting from ICU acquired weakness among the patients with mechanical ventilation.

Chest physiotherapy:a common technique to reduce the respiratory complications in ICU, has been proved certain positive influence on airway clearance and hospital lengths of stay.

No Intervention: Routine care
no physiotherapy involved

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weaning success rate
Time Frame: up to 6 weeks in respiratory care center
Weaning success was defined as patients being free from MV or BiPAP for 5 days based on Taiwan
up to 6 weeks in respiratory care center

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RCC mortality rate
Time Frame: up to 6 weeks in respiratory care center
the mortality rate of respiratory care center
up to 6 weeks in respiratory care center
hospital mortality rate
Time Frame: up to 6 weeks in respiratory care center
the mortality rate during the hospital course
up to 6 weeks in respiratory care center
discharge to home rate
Time Frame: after 6 weeks in respiratory care center
The rate of going home after discharge
after 6 weeks in respiratory care center
total mechanical ventilator use
Time Frame: up to 6 weeks in respiratory care center
The days of mechanical use during the admission time
up to 6 weeks in respiratory care center
RCC days of stay
Time Frame: up to 6 weeks in respiratory care center
The days staying in respiratory care center
up to 6 weeks in respiratory care center
total hospital days of stay
Time Frame: up to 10 weeks in the hospital
The days staying in the hospital
up to 10 weeks in the hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

June 18, 2022

Study Completion (Actual)

June 19, 2022

Study Registration Dates

First Submitted

June 20, 2022

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • TYGH111002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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