Using lung ultrasound to check for rejection in lung transplant patients
Application of Lung Ultrasound Artefact Analysis for Exclusion of Acute Rejection in Asymptomatic Lung Transplant Recipients
This study is testing if lung ultrasound can safely check for rejection and infection in lung transplant patients instead of using more invasive methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT04582279 on ClinicalTrials.gov |
What this trial studies
This study investigates a non-invasive method using lung ultrasound to diagnose acute rejection and infection in lung transplant recipients. Traditionally, lung rejection is diagnosed through bronchoscopies and biopsies, which can be risky and expensive. By utilizing lung ultrasound, the study aims to provide a safer alternative for monitoring lung health in these patients. The study will include adult lung transplant recipients who meet specific eligibility criteria, focusing on those who are asymptomatic and have normal lung function.
Who should consider this trial
Good fit: Ideal candidates for this study are adult lung transplant recipients who are asymptomatic and have normal lung function.
Not a fit: Patients who are unable to consent for the procedure or have conditions that interfere with image acquisition will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for invasive procedures in lung transplant patients, leading to better patient outcomes and lower healthcare costs.
How similar studies have performed: Other studies have shown promise in using ultrasound for diagnostic purposes, but this specific application in lung transplant rejection is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jacksonville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Tathagat Narula, MD — Mayo Clinic
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.