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

NCT ID: NCT06095609

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2022-06-19

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.

Conditions

Prolonged Weaning, Early Mobilization, Chest Physiotherapy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Early mobilization plus chest physiotherapy

Intervention Type: OTHER

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.

Routine care

no physiotherapy involved

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.).

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taoyuan General Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taoyaun General Hospital, Ministry of Wealth and Health

Taoyuan District, Taoyuan Dist., Taiwan

Countries

Taiwan

Other Identifiers

TYGH111002

Identifier Type: -

Identifier Source: org_study_id