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

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.

Study Overview

• Status: Completed
• Conditions: Mechanically Ventilation; Critically Ill, Subacute Adult Patients
• Intervention / Treatment: Procedure: Routine care; Procedure: Inspiratory muscle training

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan
    • Zuoying Armed Forces General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Inspiratory muscle training; A threshold inspiratory muscule device used a starting resistance set at 30% maximum inspiratory pressure, connecting to subject artificial airway. The subjects were then instructed to perform fast and forceful inspirations against added inspiratory resistance. The inspiratory muscle training was conducted twice daily over five consecutive days, followed by a two-day rest period. This regimen continued for three consecutive weeks or until the subject no longer required ventilator support.
Sham Comparator: Non-inspiratory muscle training; Subjects received routine care.	Procedure: Routine care; Subjects received routine care without intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days until liberation from mechanical ventilation	A record of the number of days until liberation from mechanical ventilation.	Three weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chang Gung University
• Collaborators: Zuoying Armed Forces General Hospital; Kaohsiung Chang Gung Memorial Hospital,Taiwan
• Investigators: Study Director: Shu-Jane Wang, MS, Zuoying Armed Forces General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: September 22, 2024
• First Submitted That Met QC Criteria: September 22, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: mechanical ventilation; respiratory muscle strength; respiratory muscle training; rapid shallow breathing index; sub-acute critical ill
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: KAFGHIRB107-027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data is available upon request from the principal investigator.
• IPD Sharing Time Frame: The data will become available 3 three years after the registration
• IPD Sharing Access Criteria: The data is available upon request from the principal investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No