Skip to main content
OpenTrials
Completed

NCT Number: NCT06611683

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Critically Ill, Subacute Adult Patients Critical Illness Disease Attributes Mechanically Ventilation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zuoying Armed Forces General Hospital

Kaohsiung City, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

inspiratory muscle training

Procedure

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.

Routine Care

Procedure

Subjects received routine care without intervention.

Primary outcomes

  1. Number of days until liberation from mechanical ventilation

    Time frame: Three weeks

    A record of the number of days until liberation from mechanical ventilation.

Secondary outcomes

  1. Maximum inspiratory pressure

    Time frame: Three weeks

    Maximum inspiratory pressure was measured by having each subject exert maximum inspiratory force against a pressure gauge.

  2. Maximum expiratory pressure

    Time frame: Three weeks

    Maximum expiratory pressure was measured by having each subject exert maximum expiratory force against a pressure gauge.

  3. Peak expiratory flow

    Time frame: Three weeks

    The peak expiratory flow was measured using a respiratory mechanics monitor during three forceful expirations.

  4. Peak inspiratory flow

    Time frame: Three weeks

    The peak inspiratory flow was measured using a respiratory mechanics monitor during three forceful expirations.

  5. Rapid Shallow breathing index

    Time frame: Three weeks

    The RSBI was calculated by dividing the respiratory rate by the tidal volume

Sponsors and collaborators

Lead sponsor

Chang Gung University

Other

Collaborators

  • Kaohsiung Chang Gung Memorial Hospital,Taiwan
  • Zouying Armed Forces General Hospital

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 25, 2024
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.