Lung Ultrasound Artefact Analysis for Exclusion of Acute Rejection in Lung Transplant Recipients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lung ultrasound.
- Who it may be relevant to
- Registry conditions: Post-Lung Transplantation Bronchiectasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Application of Lung Ultrasound Artefact Analysis for Exclusion of Acute Rejection in Asymptomatic Lung Transplant Recipients
Overview
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.
Interventions
- 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.
Primary outcome measures
- Establish predictive value of lung ultrasound [Time frame: Month 0 to month 12]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Mayo Clinic in Florida — Jacksonville
Identifiers
NCT: NCT04582279 · 20-002489