Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT03667027

Conditions

Diaphragm Injury

Respiratory Failure

Mechanical Ventilation Complication

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Respiratory support

Study Details

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

Study ID

NCT03667027

Start date

Apr 1, 2019

Status verified date

Dec, 2024

Completion date

Dec 30, 2025

Anticipated

Primary completion date

Aug 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Respiratory support

Mechanical ventilation or extracorporeal life support

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Rongyu (Cindy) Jin

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

Locations

Toronto General Hospital

Recruiting

Toronto, Canada

Contacts

Jenna Wong, MSc

4163404800jenna.wong@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 11, 2024

Last verified

Dec, 2024

Keywords

  • Diaphragm Dysfunction
  • Acute Respiratory Failure
  • Mechanical Ventilation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2024-12-11.