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

Mayo Clinic

Status: Enrolling

Conditions: Post-Lung Transplantation Bronchiectasis

Treatments: Diagnostic Test: Lung ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT04582279

20-002489

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

Receiving Ultrasound

Experimental group

Description:

Every patient will receive a lung ultrasound prior to each scheduled bronchoscopy until the study stops.

Treatment:

Diagnostic Test: Lung ultrasound