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| Name | Class |
|---|---|
| The Hospital for Sick Children | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing LTx with respiratory failure (cases) | Patients are receiving a respiratory support modality (mechanical ventilation and/or extracorporeal life support) as a bridge to lung transplantation (LTx). |
| |
| Patients undergoing LTx without prior respiratory support | Patients undergoing lung transplantation but do not require prior bridging respiratory support. | ||
| Elective thoracic surgical patients | Patients undergoing elective thoracic surgery for planned lung or esophageal resection. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respiratory support | Device | Mechanical ventilation or extracorporeal life support |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria (Cases):
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):
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Patients with acute respiratory failure awaiting lung transplantation who are being bridged to lung transplantation either by mechanical ventilation or extracorporeal life support.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rongyu (Cindy) Jin | Contact | 416-340-4800 | 7613 | rongyu.jin@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Ewan Goligher, MD, PhD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto General Hospital | Recruiting | Toronto | Canada |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Diaphragm tissue Blood
| 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 |