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

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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