- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06095609
The Implementation of Early Mobilization and Chest Physiotherapy on Weaning Rate of Prolong Weaning Patients.
The Implementation of Early Mobilization and Chest Physiotherapy on Weaning Rate of Prolong Weaning Patients. A Retrospective Study
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Taoyuan Dist.
-
Taoyuan, Taoyuan Dist., Taiwan, 330
- Taoyaun General Hospital, Ministry of Wealth and Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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