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OpenTrials
Completed

NCT Number: NCT04103996

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

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

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Key information

Conditions

Diaphragm Injury Lung Transplant; Complications, Mechanical Mechanical Ventilation Complication Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Toronto General Hospital

Toronto, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound

Diagnostic Test

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

Diagnostic Test

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.

Primary outcomes

  1. Incidence of diaphragm dysfunction at the first spontaneous breathing trial and at ICU discharge after lung transplantation

    Time frame: 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 outcomes

  1. Pre-transplant diaphragm thickness and function compared to post-transplant diaphragm dysfunction

    Time frame: 1 day

    Diaphragm thickness and function documented on ultrasound will be assessed

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Acronym: RADAR

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 26, 2019
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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