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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date May 2024
Source University Health Network, Toronto
Contact Rongyu (Cindy) Jin
Phone 416-340-4800
Email rongyu.jin@uhn.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Respiratory support
Mechanical ventilation or extracorporeal life support

Locations

Country Name City State
Canada Toronto General Hospital Toronto

Sponsors (2)

Lead Sponsor Collaborator
University Health Network, Toronto The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

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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