90 Participants Needed

Lung Ultrasound for Lung Transplant

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This trial is looking for a safer and cheaper way to check for lung problems in lung transplant patients without using risky procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Lung Ultrasound for Lung Transplant?

Lung ultrasound is effective in identifying complications like pleural effusions (fluid around the lungs) and pneumonias after lung transplants, and it is a reliable tool for monitoring lung conditions without radiation exposure.12345

Is lung ultrasound safe for humans?

Lung ultrasound is generally considered safe for humans as it is a non-invasive and non-irradiating tool used widely in medical settings, including critical care and emergency medicine. However, the safety of ultrasound, especially on the lungs, is important due to specific effects at the air-tissue interface, and recommendations exist to ensure safe use.16789

How is lung ultrasound treatment different from other treatments for lung transplant patients?

Lung ultrasound is unique because it is a non-invasive, bedside tool that does not use radiation, making it safe for frequent monitoring. It allows for real-time assessment of lung conditions, such as pleural effusions and pneumonias, especially in the early postoperative phase after lung transplantation.123710

Research Team

TN

Tathagat Narula, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults over 18 who have had a lung or heart-lung transplant. They must be symptom-free, with clear chest X-rays and normal breathing test results (FEV1) that haven't dropped more than 10% from their usual. People can't join if they can't consent or have conditions like subcutaneous emphysema that make it hard to get good ultrasound images.

Inclusion Criteria

Clear chest radiograph over allograft
You do not have any symptoms related to the medical condition being studied.
Normal spirometry defined as a FEV1 without significant drop from baseline (significant drop = >10% decrease from baseline)
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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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lung ultrasounds prior to each scheduled bronchoscopy to diagnose lung rejection and infection

12 months
Monthly visits for ultrasound and bronchoscopy

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Lung ultrasound
Trial OverviewThe study is testing the use of lung ultrasounds as a non-invasive method to detect lung rejection and infection in patients who've received lung transplants. It aims to find safer ways to diagnose these serious complications without invasive procedures.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Receiving UltrasoundExperimental Treatment1 Intervention
Every patient will receive a lung ultrasound prior to each scheduled bronchoscopy until the study stops.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Findings from Research

Lung ultrasound is a safe, non-irradiating tool that can effectively monitor lung conditions, particularly in critical care settings, by quantifying lung aeration and guiding treatment decisions.
In a case of severe interstitial lung disease linked to dermatomyositis-polymyositis, daily lung ultrasound scores were instrumental in assessing the patient's response to immunosuppressive therapy, especially when traditional imaging methods like chest X-rays were inadequate.
Combined ultrasound-CT approach to monitor acute exacerbation of interstitial lung disease.Mongodi, S., Colombo, A., Orlando, A., et al.[2020]
Lung ultrasound (LUS) is a feasible and effective tool for identifying pulmonary complications such as pleural effusions and pneumonias in lung transplant recipients during the early postoperative phase, as demonstrated in a study of 14 patients.
The study found that pleural effusion was most common at week 2 post-transplant, with high detection rates (up to 92.9%), while pneumonia cases peaked during the same period but decreased thereafter, indicating LUS's utility in monitoring these conditions over time.
Lung Ultrasound in the Assessment of Pulmonary Complications After Lung Transplantation.Davidsen, JR., Schultz, HHL., Henriksen, DP., et al.[2022]
Lung ultrasound is an effective tool for assessing pulmonary involvement in cystic fibrosis patients, showing significant correlations with pulmonary function measures like FVC% and FEV1%, as well as nutritional status indicators such as body mass index and weight.
In a study of 18 cystic fibrosis patients, lung ultrasound findings correlated well with the modified Bhalla score, suggesting it can serve as a reliable alternative to high-resolution computed tomography for evaluating lung health in these patients.
The Use of Ultrasound as a Tool to Evaluate Pulmonary Disease in Cystic Fibrosis.Peixoto, AO., Marson, FA., Dertkigil, SS., et al.[2020]

References

Combined ultrasound-CT approach to monitor acute exacerbation of interstitial lung disease. [2020]
Lung Ultrasound in the Assessment of Pulmonary Complications After Lung Transplantation. [2022]
The Use of Ultrasound as a Tool to Evaluate Pulmonary Disease in Cystic Fibrosis. [2020]
B-Mode Ultrasound Findings in a Patient With Suspected Pulmonary Gangrene. [2021]
Lung Ultrasound in Emergency and Critically Ill Patients: Number of Supervised Exams to Reach Basic Competence. [2020]
Assessment of lung injury severity using ultrasound in critically ill COVID-19 patients in resource limited settings. [2023]
The impact of lung ultrasound on clinical-decision making across departments: a systematic review. [2022]
Best Practice Recommendations for the Safe use of Lung Ultrasound. [2023]
Lung Ultrasound in Critical Care and Emergency Medicine: Clinical Review. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Lung Ultrasound for the Cardiologist. [2019]