Understanding diaphragm changes in patients awaiting lung transplants
Official title: Diaphragm Structure and Pathobiology in Patients Being Bridged to Lung Transplant
Run by University Health Network, Toronto · NCT03667027 · Data updated 2026-11-12
This study looks at how different breathing support methods affect the diaphragm in patients waiting for lung transplants to find ways to reduce diaphragm damage.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto) |
| Status | Recruiting |
| Started | April 1, 2019 |
| Main results expected | August 30, 2025 |
| Study ends | December 30, 2025 |
| Registry record updated | December 11, 2024 |
| Trial ID | NCT03667027 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients receiving respiratory support as a bridge to lung transplantation who are formally listed for transplantation.
✕Probably not a fit
Patients with a history of neuromuscular disorders or those who have received invasive mechanical ventilation for more than 48 hours in the past four weeks may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to characterize the structural and functional changes in the diaphragm of patients who are being bridged to lung transplantation using mechanical ventilation or extracorporeal life support. It investigates how different respiratory support methods impact diaphragm injury and dysfunction, which can complicate weaning from mechanical ventilation. By employing bedside ultrasound to measure diaphragm thickness, the study seeks to correlate these ultrasound findings with histological changes observed in diaphragm tissues. The ultimate goal is to identify strategies to minimize diaphragm injury during respiratory support.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for preserving diaphragm function in patients awaiting lung transplants, enhancing their recovery and weaning from mechanical ventilation.
How similar studies have gone: While diaphragm injury during mechanical ventilation is a recognized issue, this specific approach using ultrasound to correlate structural changes with histological data is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria (Cases): * Receiving a respiratory support modality as a bridge to lung transplantation * Formally listed for transplantation Inclusion Criteria (Control Group 1): \- Undergoing lung transplantation for either obstructive or restrictive lung disease Inclusion Criteria (Control Group 2): \- Undergoing elective thoracic surgery without any prior history of chronic pulmonary parenchymal disease Exclusion Criteria (Cases and Controls): * Previously diagnosed with neuromuscular disorder * Received invasive mechanical ventilation for \>48 hours in the preceding four weeks * Thoracic cage deformity
Where it's running
-
Toronto General Hospital
Toronto, 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: 416-340-4800
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.