Understanding respiratory muscle changes in patients on mechanical ventilation
Respiratory Muscle Structure and Function in Mechanically Ventilated Patients and Long-term Outcomes
This study looks at how breathing muscles change in patients on mechanical ventilation to see how it affects their recovery and quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 230 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05857774 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize the changes in respiratory muscle structure and function in patients undergoing mechanical ventilation. It will evaluate how diaphragm and abdominal muscle atrophy during ventilation affects long-term outcomes and quality of life. By utilizing sonographic, physiological, and biological measurements, the study seeks to uncover the relationship between these muscle groups and their impact on recovery from respiratory failure. The findings could help identify patients at risk for prolonged mechanical ventilation and adverse outcomes.
Who should consider this trial
Good fit: Ideal candidates include adult patients aged 18 and older who are undergoing invasive mechanical ventilation in the ICU within 36 hours of intubation.
Not a fit: Patients expected to be extubated within 24 hours of screening or those with previously diagnosed neuromuscular disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for managing patients on mechanical ventilation, potentially enhancing their recovery and quality of life.
How similar studies have performed: While diaphragm atrophy during mechanical ventilation has been linked to adverse outcomes in previous studies, the specific relationship between abdominal muscle atrophy and long-term outcomes is less understood, making this study a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Cases Inclusion Criteria: • Adult patients ≥18 years of age undergoing invasive mechanical ventilation in the ICU for any reason within 36 hours of intubation Control condition A Inclusion Criteria: • Non-invasively ventilated patients in the ICU within 36 hours of initiating non-invasive ventilation Control condition B Inclusion Criteria • Non-ventilated patients admitted to the ICU receiving no respiratory support or oxygen therapy alone, including high flow nasal cannula Exclusion Criteria: * Patients expected to be extubated within 24 hours of screening for eligibility * Patients who have already undergone a SBT at time of screening * Patients with a previously diagnosed neuromuscular disorder * Patients receiving long-term invasive mechanical ventilation (prior to current hospitalization) * Patients who have required previously (during current hospitalization) a period of invasive ventilation in ICU of more than 24 hours * Patients who have previously been enrolled in the study * Patients for whom post-hospital follow-up may be challenging, e.g. those who reside overseas or who have no fixed address
Where this trial is running
Toronto, Ontario
- Toronto General Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Ewan Goligher, MD, PhD — University Health Network, Toronto
- Study coordinator: Rongyu (Cindy) Jin
- Email: rongyu.jin@uhn.ca
- Phone: 4163404800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.