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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-10

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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).

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ewan Goligher, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UHN Toronto

Locations

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Toronto General Hospital

Toronto, , Canada

Site Status

Countries

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Canada

Other Identifiers

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19-5894

Identifier Type: -

Identifier Source: org_study_id