Incidence, Risk Factors and Outcomes of Diaphragm Dysfunction After Lung Transplantation

Completed

• Conditions: Diaphragm Injury; Respiratory Failure; Lung Transplant; Complications, Mechanical; Mechanical Ventilation Complication

• Registration Number: NCT04103996
• Lead Sponsor: University Health Network, Toronto

Brief Summary

The study is designed to characterize the changes in diaphragm function after lung transplantation.

Detailed Description

Diaphragm dysfunction (DD) is a well-known complication after lung transplantation. Patients with an injured and dysfunctional diaphragm have greater difficulty weaning from mechanical ventilation post-transplant - they become too weak to breathe. However, little is known about the pre-transplant predictive factors associated with diaphragm dysfunction . We have developed a new technique employing beside ultrasound to measure diaphragm thickness. This allows us to observe changes in diaphragm muscle structure and function.

The goal of the study is to determine whether pre-transplant diaphragm thickness and function are associated with diaphragmatic dysfunction after lung transplantation. This will help us to confirm the best way to avoid diaphragm injury and to understanding the meaning of diaphragm ultrasound images.

Study Timeline

• Study First Submitted: 2019-08-27
• Study First Submitted QC: 2019-09-23
• Study First Posted: 2019-09-26
• Study Start: 2020-02-10
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Adult patients greater than 18 years of age
• Listed for lung transplantation

Read More

Exclusion Criteria

• Known diagnosis of chronic neuromuscular disease
• Relisting for transplantation
• Bridging to lung transplantation with respiratory support

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of diaphragm dysfunction at the first spontaneous breathing trial and at ICU discharge after lung transplantation	First spontaneous breathing trial, an average of 1 to 7 days	Diaphragm ultrasound will be used to visualize diaphragm dysfunction (maximal thickening fraction \<20%)

Secondary Outcome Measures

Name	Time	Method
Pre-transplant diaphragm thickness and function compared to post-transplant diaphragm dysfunction	1 day	Diaphragm thickness and function documented on ultrasound will be assessed

Trial Locations

Locations (1)

Toronto General Hospital; 🇨🇦 Toronto, Canada