Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04658498

Improving Our Understanding of Respiratory Muscle Training to Facilitate Weaning From Mechanical Ventilation in the ICU

Led by KU Leuven · Updated on 2026-03-18

90

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Mechanical ventilation is a critical treatment used in intensive care units but can cause weakness and loss of muscle in the respiratory muscles. This weakness is linked to longer ventilation times, difficulty in stopping ventilation, and higher mortality in the ICU. Researchers are studying how respiratory muscle training affects muscle function in patients who have trouble weaning off mechanical ventilation, aiming to better understand the physiological changes in response to different training methods. The study compares three approaches during the weaning period: usual care with intermittent spontaneous breathing, usual care plus high-intensity inspiratory muscle training (IMT) using a tapered flow resistive device, and usual care plus low-intensity (sham) IMT. The high-intensity training involves supervised daily sessions with increasing resistance to improve breathing muscle strength, while the low-intensity group uses minimal resistance as a control. The study will investigate which training method provides better respiratory muscle conditioning. Participants will be monitored for up to 28 days during the training period. Researchers will assess maximal inspiratory pressure and use ultrasound to measure diaphragm movement and thickness. They will also analyze muscle tissue changes, blood flow, oxygen levels, and electrical activity of respiratory muscles. These assessments will help measure muscle strength, structure, and function. The study aims to optimize muscle training to aid patients in successfully stopping mechanical ventilation.

CONDITIONS

Brief Title

Improving Our Understanding of Respiratory Muscle Training to Facilitate Weaning From Mechanical Ventilation in the ICU

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Difficult and prolonged weaning patients
  • Adequate oxygenation
  • Febrile temperature below 38ºC
  • Hemodynamic stability
  • Stable blood pressure
  • No or minimal use of vasopressors
  • No myocardial ischemia
  • Adequate hemoglobin and mental status
  • Resolution of acute phase of disease
  • Able to follow simple verbal commands related to inspiratory muscle training
  • Mechanically ventilated via tracheostomy or endotracheal tube
Not Eligible

You will not qualify if you...

  • Pre-existing neuromuscular disease
  • Agitation
  • Hemodynamically unstable conditions such as arrhythmia, decompensated heart failure, or coronary insufficiency
  • Hemoptysis
  • Diaphoresis
  • Spinal cord injury above T8
  • Use of any home mechanical ventilation support before hospitalization
  • Skeletal problems impairing chest wall movements
  • Poor overall prognosis or expected fatal outcome

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to 28 days

Participants receive usual care with intermittent spontaneous breathing periods and are randomly assigned to either high-intensity or low-intensity inspiratory muscle training using a tapered flow resistive device.

Daily supervised training sessions

Trial Site Locations

Total: 1 location

1

University Hospital Leuven

Leuven, Belgium, 3000

Actively Recruiting

Loading map...

Research Team

D

Daniel Langer, PT, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Similar Trials

Effect of Hypophosphatemia on Neuro-excursion Efficiency Dur...

Mechanical Ventilation

Actively Recruiting

1 location

Estimation of Diaphragm Electrical Activity and Intercostal ...

Respiratory Failure

Actively Recruiting

1 location

Clinical Safety and Feasibility Study of heepSync for Electr...

Ventilator-induced Diaphragm Dysfunction

Actively Recruiting

3 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Diaphragm function and weaning from mechanical ventilation: an ultrasound and phrenic nerve stimulation clinical study.

Martin Dres, Ewan C Goligher, Bruno-Pierre Dubé...

https://pubmed.ncbi.nlm.nih.gov/29687276

Inspiratory muscle training facilitates weaning from mechanical ventilation among patients in the intensive care unit: a systematic review.

Mark Elkins, Ruth Dentice

https://pubmed.ncbi.nlm.nih.gov/26092389

Efficacy of a Novel Method for Inspiratory Muscle Training in People With Chronic Obstructive Pulmonary Disease.

Daniel Langer, Noppawan Charususin, Cristina Jácome...

https://pubmed.ncbi.nlm.nih.gov/25858974

Can inspiratory muscle training improve weaning outcomes in difficult to wean patients? A protocol for a randomised controlled trial (IMweanT study).

Mariana Hoffman, Marine Van Hollebeke, Beatrix Clerckx...

https://pubmed.ncbi.nlm.nih.gov/29961023

Inspiratory effort and respiratory muscle activation during different breathing conditions in patients with weaning difficulties: An exploratory study.

Diego Poddighe, Marine Van Hollebeke, Beatrix Clerckx...

https://pubmed.ncbi.nlm.nih.gov/39842329