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

Sponsor
Taoyuan General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06095609
Collaborator
(none)
202
1
2
18
341.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Early mobilization plus chest physiotherapy
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
202 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The study retrospectively reviewed the medical record from the medical team. Patients before 2019/01/01 who didn't receive physiotherapy are regarded as control group. Patients after 2019/01/01 are assigned to the experiment group.The study retrospectively reviewed the medical record from the medical team. Patients before 2019/01/01 who didn't receive physiotherapy are regarded as control group. Patients after 2019/01/01 are assigned to the experiment group.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Implementation of Early Mobilization and Chest Physiotherapy on Weaning Rate of Prolong Weaning Patients. A Retrospective Study
Actual Study Start Date :
Jun 1, 2022
Actual Primary Completion Date :
Jun 18, 2022
Actual Study Completion Date :
Jun 19, 2022

Arms and Interventions

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.

Other: Early mobilization plus chest physiotherapy
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

Outcome Measures

Primary Outcome Measures

  1. Weaning success rate [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

Secondary Outcome Measures

  1. RCC mortality rate [up to 6 weeks in respiratory care center]

    the mortality rate of respiratory care center

  2. hospital mortality rate [up to 6 weeks in respiratory care center]

    the mortality rate during the hospital course

  3. discharge to home rate [after 6 weeks in respiratory care center]

    The rate of going home after discharge

  4. total mechanical ventilator use [up to 6 weeks in respiratory care center]

    The days of mechanical use during the admission time

  5. RCC days of stay [up to 6 weeks in respiratory care center]

    The days staying in respiratory care center

  6. total hospital days of stay [up to 10 weeks in the hospital]

    The days staying in the hospital

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
  1. Patient who didn't meet the criteria of received physiotherapy (Figure 1.).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Taoyaun General Hospital, Ministry of Wealth and Health Taoyuan Taoyuan Dist. Taiwan 330

Sponsors and Collaborators

  • Taoyuan General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taoyuan General Hospital
ClinicalTrials.gov Identifier:
NCT06095609
Other Study ID Numbers:
  • TYGH111002
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 23, 2023