Actively Recruiting
Diaphragm Structure and Pathobiology in Patients Being Bridged to Lung Transplant
Led by University Health Network, Toronto · Updated on 2024-12-11
40
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
T
The Hospital for Sick Children
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying changes in the diaphragm's structure, function, and biology in patients who are supported by mechanical ventilation or extracorporeal life support as they wait for lung transplantation. The study aims to understand how these different respiratory support methods may cause diaphragm injury and how these injuries relate to tissue changes seen under a microscope. This research may help improve methods to prevent diaphragm damage and interpret ultrasound images of the diaphragm. Participants include patients receiving mechanical ventilation or extracorporeal life support as a bridge to lung transplant, patients undergoing lung transplantation without prior respiratory support, and patients having elective thoracic surgery for lung or esophageal resection. The study uses bedside ultrasound to measure diaphragm thickness and compares these findings to tissue samples obtained during transplantation or surgery. During the study, participants will have ultrasound assessments to track diaphragm thickness and function, and tissue samples will be examined microscopically to identify structural changes. Researchers will monitor diaphragm thickness changes at baseline and 7 days after lung transplant, and assess biomarkers related to diaphragm dysfunction before transplantation. The study is observational, and participants are involved through routine clinical procedures and additional ultrasound and tissue evaluations.
CONDITIONS
Brief Title
Diaphragm Structure and Pathobiology in Patients Being Bridged to Lung Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Receiving a respiratory support modality as a bridge to lung transplantation
- Formally listed for transplantation
- Undergoing lung transplantation for either obstructive or restrictive lung disease
- Undergoing elective thoracic surgery without any prior history of chronic pulmonary parenchymal disease
You will not qualify if you...
- Previously diagnosed with neuromuscular disorder
- Received invasive mechanical ventilation for >48 hours in the preceding four weeks
- Thoracic cage deformity
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of respiratory support prior to lung transplant or surgery
Participants undergo respiratory support via mechanical ventilation or extracorporeal life support as part of routine care before lung transplantation or elective thoracic surgery. Measurements of diaphragm thickness are collected using bedside ultrasound.
Multiple ultrasound assessments before transplantation or surgery
Duration - At transplantation or surgery
Diaphragm tissue samples are collected at the time of transplantation or surgery to analyze histological features of diaphragm dysfunction.
1 visit (in-person)
Duration - Up to 7 days after lung transplant
Participants are observed to assess changes in diaphragm thickness and function after lung transplantation or elective surgery.
1 follow-up visit at 7 days post-transplant
Trial Site Locations
Total: 1 location
1
Toronto General Hospital
Toronto, Canada
Actively Recruiting
Research Team
R
Rongyu (Cindy) Jin
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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