Respiratory Failure Clinical Trial
— DIASPORAOfficial title:
Diaphragm Structure and Pathobiology in Patients Being Bridged to Lung Transplant
NCT number | NCT03667027 |
Other study ID # | 18-5660 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2019 |
Est. completion date | December 30, 2024 |
This study is designed to characterize the changes in diaphragm structure, function and biology during bridging to lung transplant by mechanical ventilation or extracorporeal life support.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 30, 2024 |
Est. primary completion date | October 30, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Toronto General Hospital | Toronto |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | The Hospital for Sick Children |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in diaphragm thickness and thickening fraction in patients using MV and patients using ECLS | Diaphragm thickness and injury score will be tested for an interaction between the bridging modality (MV vs. ECLS) and the duration of exposure to the modality on the degree of diaphragm injury and atrophy | Change from baseline diaphragm thickness and thickening fraction at 7 days after lung transplant | |
Secondary | Correlate changes in diaphragm thickness and histological features of diaphragm dysfunction | Histological features to be assessed are: myofibril cross-sectional area, muscle fiber type, presence of cellular infiltrates, myofiber necrosis and regeneration, autophagy and fibro-fatty infiltration | Assessed immediately after transplantation | |
Secondary | Biomarkers for diaphragm dysfunction | Biomarkers to be assessed are: skeletal troponin-I and markers of systemic inflammation (IL-1, IL-6, Tumor Necrosis Factor (TNF)-alpha) | Assessed immediately before transplantation |
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