Diaphragm Structure and Pathobiology in Patients Being Bridged to Lung Transplant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Respiratory support.
- Who it may be relevant to
- Registry conditions: Diaphragm Injury, Respiratory Failure, Mechanical Ventilation Complication. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Mechanical ventilation has been linked to diaphragm injury and dysfunction. During mechanical ventilation, the amount of breathing work done by the diaphragm is unpredictable: the diaphragm could be completely rested, or it could be overworked. Either of these possibilities may cause injury to the diaphragm. Patients with an injured and dysfunctional diaphragm have greater difficulty weaning from mechanical ventilation - they become too weak to breathe. However, little is known about the relationship between changes in the diaphragm and the histological (structure of cells and tissue) basis of these changes. The investigators have developed a new technique employing beside ultrasound to measure diaphragm thickness. This allows them to observe changes in diaphragm muscle structure and function.
The goal of the study is to determine whether different forms of respiratory support (mechanical ventilation vs extracorporeal life support) lead to different degrees of diaphragm injury and to compare changes in the diaphragm seen on ultrasound to changes in the diaphragm tissues under a microscope. This will help the investigators to confirm the best way to avoid diaphragm injury and to understanding the meaning of diaphragm ultrasound images.
Interventions
- Device Respiratory support
Mechanical ventilation or extracorporeal life support
Primary outcome measures
- Difference in diaphragm thickness and thickening fraction in patients using MV and patients using ECLS [Time frame: Change from baseline diaphragm thickness and thickening fraction at 7 days after lung transplant]
Secondary outcome measures (2)
- Correlate changes in diaphragm thickness and histological features of diaphragm dysfunction [Time frame: Assessed immediately after transplantation]
- Biomarkers for diaphragm dysfunction [Time frame: Assessed immediately before transplantation]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Canada · 1 center
- Toronto General Hospital — Toronto
Identifiers
NCT: NCT03667027 · 18-5660