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

Respiratory Failure Clinical Trial

— RADAR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04103996
• Other study ID #: 19-5894
• Status: Active, not recruiting
• Start date: February 10, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2022
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 1, 2023
• Est. primary completion date: November 1, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Ultrasound
Sonographic measurements (diaphragm, abdominal muscle, and quadriceps thickness) will be acquired when listed for lung transplantation. Sonographic measurements will be recorded on a daily basis for up to 1 week after transplantation (while the patient remains intubated).
• Respiratory function measurements
Maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP) will be acquired after listing for lung transplantation. After transplant, MIP will be recorded once patients are eligible for a trial of spontaneous breathing and weekly thereafter. MEP will also be recorded at ICU discharge.

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pre-transplant diaphragm thickness and function compared to post-transplant diaphragm dysfunction	Diaphragm thickness and function documented on ultrasound will be assessed	1 day