Diaphragm Structure and Pathobiology in Patients Being Bridged to Lung Transplant

NCT03667027 | Recruiting

• 1 other identifier: 18-5660
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diaphragm Injury; Respiratory Failure; Mechanical Ventilation Complication

Keywords

Diaphragm Dysfunction; Acute Respiratory Failure; Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Correlate changes in diaphragm thickness and histological features of diaphragm dysfunction

  Assessed immediately after transplantation

• Biomarkers for diaphragm dysfunction

  Assessed immediately before transplantation

Study Arms (3)

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).

Device: Respiratory support

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.

Interventions

Respiratory support DEVICE

Mechanical ventilation or extracorporeal life support

Patients undergoing LTx with respiratory failure (cases)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute respiratory failure awaiting lung transplantation who are being bridged to lung transplantation either by mechanical ventilation or extracorporeal life support.

You may qualify if:

• 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 may not qualify if:

• Previously diagnosed with neuromuscular disorder
• Received invasive mechanical ventilation for \>48 hours in the preceding four weeks
• Thoracic cage deformity

Sponsors & Collaborators

• University Health Network, Toronto: lead
• The Hospital for Sick Children: collaborator

Study Sites (1)

Toronto General Hospital

Toronto, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Diaphragm tissue Blood

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Ewan Goligher, MD, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rongyu (Cindy) Jin

CONTACT

416-340-4800; rongyu.jin@uhn.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 12, 2018
• Study Start: April 1, 2019
• Primary Completion: August 30, 2025
• Study Completion: December 30, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)