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

NCT04103996 | Completed

• 1 other identifier: 19-5894
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pre-transplant diaphragm thickness and function compared to post-transplant diaphragm dysfunction

  1 day

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Canada

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ewan Goligher, MD, PhD

  UHN Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: September 26, 2019
• Study Start: February 10, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)