Lung Ultrasound Artefact Analysis for Exclusion of Acute Rejection in Lung Transplant Recipients

Post-Lung Transplantation Bronchiectasis Clinical Trial

Official title:

Application of Lung Ultrasound Artefact Analysis for Exclusion of Acute Rejection in Asymptomatic Lung Transplant Recipients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04582279
• Other study ID #: 20-002489
• Status: Recruiting
• Phase: N/A
• Start date: October 28, 2020
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is being done to study a safe and non-invasive way to diagnose lung rejection and infection.

Description:

Lung transplant recipients are at high risk for lung rejection and lung infection after transplant. This is diagnosed by performing lung bronchoscopies and lung biopsies. These procedures carry an increased risk for complications and are costly. This study is being done to study a safe and non-invasive way to diagnose lung rejection and infection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (> 18 yrs) who had undergone single/double/heart-lung transplant

• Asymptomatic

• Normal spirometry defined as a FEV1 without significant drop from baseline (significant drop = >10% decrease from baseline)

• Clear chest radiograph over allograft

Exclusion Criteria:

• Patients who are unable to consent for the procedure

• Patients with subcutaneous emphysema or other technical challenges that could interfere with satisfactory image acquisition- as deemed by the operator.

Related Conditions & MeSH terms

• Bronchiectasis
• Post-Lung Transplantation Bronchiectasis

Intervention

Diagnostic Test:
• Lung ultrasound
The lung ultrasound will be performed by a trained pulmonologist by gently pressing a probe to various areas of your chest. This is a non-invasive procedure and you should not feel any pain. The ultrasound will take less than 10 minutes.

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish predictive value of lung ultrasound	Determine if lung ultrasound provides the same diagnostic results as bronchoscopy and biopsy	Month 0 to month 12