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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04103996
Acronym
RADAR
Enrollment
15
Registered
2019-09-26
Start date
2020-02-10
Completion date
2021-12-31
Last updated
2024-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIAGNOSTIC_TESTUltrasound

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).

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.

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of diaphragm dysfunction at the first spontaneous breathing trial and at ICU discharge after lung transplantationFirst spontaneous breathing trial, an average of 1 to 7 daysDiaphragm ultrasound will be used to visualize diaphragm dysfunction (maximal thickening fraction \<20%)

Secondary

MeasureTime frameDescription
Pre-transplant diaphragm thickness and function compared to post-transplant diaphragm dysfunction1 dayDiaphragm thickness and function documented on ultrasound will be assessed

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026