Effect of Inspiratory Muscle Training on Ventilated Patients in an Intensive Care Unit

Not Applicable

Completed

• Conditions: Critically Ill, Subacute Adult Patients; Mechanically Ventilation
• Interventions: Procedure: Inspiratory muscle training; Procedure: Routine care

• Registration Number: NCT06611683
• Lead Sponsor: Chang Gung University

Brief Summary

The goal of this clinical trial is to learn if inspiratory muscle training facilite the liberation of mechanical ventilation. The main questions it aims to answer are:

Does inspiratory muscle training facilitate weaning from mechanical ventilation and enhance muscle strength in critically ill, subacute adult patients?

The main questions it aims to answer are:

Does pulmonary rehabilitation facilitate wwaning form mechanical patients? Does the intervention improve respiratory muscle strength and respiratory patterns?

Participants received:

Inspriatory muscle training twice daily for three consecutive weeks or until the subject no longer required ventilator support.

Detailed Description

Patients on mechanical ventilation often experience rapid diaphragm atrophy on the second day, resulting in muscle fiber changes, respiratory muscle weakness. Clinical studies have explored enhancing diaphragm and respiratory muscle strength and endurance through inspiratory muscle, expiratory muscle, and combined respiratory muscle training. This study was to determine if inspiratory muscle training significantly facilitates liberation from mechanical ventilation and improves muscle strength when compared to without IMT among subacute critically ill adult patients.

Study Timeline

• Study Start: 2019-07-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2024-09
• Study First Submitted: 2024-09-22
• Study First Submitted QC: 2024-09-22
• Study First Posted: 2024-09-25
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• requiring invasive mechanical ventilation for 2 days in an ICU

Exclusion Criteria

• hemodynamic instability (heart rate 120 beats/min, unstable blood pressure, vasopressor infusion)
• inadequate oxygenation (PEEP 8 cmH2O, FiO2 50%)
• body temperature 38.5°C
• sepsis
• use of sedative infusion
• steroid administration
• home ventilator use before ICU admission

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inspiratory Muscle Training	Inspiratory muscle training	Subjects received inspiratory muscle training twice daily over five consecutive days, followed by a two-day rest period. This regimen was continued for three consecutive weeks or until the subject no longer required ventilator support.
Non-inspiratory muscle training	Routine care	Subjects received routine care.

Primary Outcome Measures

Name	Time	Method
Number of days until liberation from mechanical ventilation	Three weeks	A record of the number of days until liberation from mechanical ventilation.

Secondary Outcome Measures

Name	Time	Method
Maximum inspiratory pressure	Three weeks	Maximum inspiratory pressure was measured by having each subject exert maximum inspiratory force against a pressure gauge.
Maximum expiratory pressure	Three weeks	Maximum expiratory pressure was measured by having each subject exert maximum expiratory force against a pressure gauge.
Peak expiratory flow	Three weeks	The peak expiratory flow was measured using a respiratory mechanics monitor during three forceful expirations.
Peak inspiratory flow	Three weeks	The peak inspiratory flow was measured using a respiratory mechanics monitor during three forceful expirations.
Rapid Shallow breathing index	Three weeks	The RSBI was calculated by dividing the respiratory rate by the tidal volume

Trial Locations

Locations (1)

Zuoying Armed Forces General Hospital; 🇨🇳 Kaohsiung, Taiwan