NCT06095609

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 20, 2022

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
Last Updated

October 23, 2023

Status Verified

September 1, 2022

Enrollment Period

17 days

First QC Date

June 20, 2022

Last Update Submit

October 18, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Weaning success rate

    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 Outcomes (6)

  • RCC mortality rate

    up to 6 weeks in respiratory care center

  • hospital mortality rate

    up to 6 weeks in respiratory care center

  • discharge to home rate

    after 6 weeks in respiratory care center

  • total mechanical ventilator use

    up to 6 weeks in respiratory care center

  • RCC days of stay

    up to 6 weeks in respiratory care center

  • +1 more secondary outcomes

Study Arms (2)

Early mobilization plus chest physiotherapy

EXPERIMENTAL

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

Routine care

NO INTERVENTION

no physiotherapy involved

Interventions

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.

Early mobilization plus chest physiotherapy

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taoyaun General Hospital, Ministry of Wealth and Health

Taoyuan District, Taoyuan Dist., 330, Taiwan

Location

MeSH Terms

Interventions

Early Ambulation

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2022

First Posted

October 23, 2023

Study Start

June 1, 2022

Primary Completion

June 18, 2022

Study Completion

June 19, 2022

Last Updated

October 23, 2023

Record last verified: 2022-09

Locations