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
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Receiving Ultrasound Lung ultrasound Every patient will receive a lung ultrasound prior to each scheduled bronchoscopy until the study stops.
- Primary Outcome Measures
Name Time Method Establish predictive value of lung ultrasound Month 0 to month 12 Determine if lung ultrasound provides the same diagnostic results as bronchoscopy and biopsy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic in Florida
🇺🇸Jacksonville, Florida, United States