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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Respiratory Failure; Mechanical Ventilation Complication; Diaphragm Injury; Lung Transplant; Complications, Mechanical
• Intervention / Treatment: Diagnostic test: Ultrasound; Diagnostic test: Respiratory function measurements

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Canada
  • Toronto, Canada
    • Toronto General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

We plan to enroll a total of 100 patients who were listed and will benefit from lung transplant

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-transplant diaphragm thickness and function compared to post-transplant diaphragm dysfunction	Diaphragm thickness and function documented on ultrasound will be assessed	1 day

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2020
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: August 27, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 19-5894

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No