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

Not Applicable
Recruiting
Conditions
Post-Lung Transplantation Bronchiectasis
Interventions
Diagnostic Test: Lung ultrasound
Registration Number
NCT04582279
Lead Sponsor
Mayo Clinic
Brief Summary

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

Detailed 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 & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
90
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
Read More
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.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Receiving UltrasoundLung ultrasoundEvery patient will receive a lung ultrasound prior to each scheduled bronchoscopy until the study stops.
Primary Outcome Measures
NameTimeMethod
Establish predictive value of lung ultrasoundMonth 0 to month 12

Determine if lung ultrasound provides the same diagnostic results as bronchoscopy and biopsy

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Mayo Clinic in Florida

🇺🇸

Jacksonville, Florida, United States

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