Lung Ultrasound for Lung Transplant

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Subcutaneous emphysema, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

90 Participants Needed

What You Need to Know Before You Apply

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.

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. ^{1 2 3 4 5}

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. ^{2 4 6 7 8}

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. ^{4 6 8 9 10}

Who Is on the Research Team?

Tathagat Narula, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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)

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Lung ultrasound

Trial Overview The 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.

How Is the Trial Designed?

Group I: Receiving Ultrasound Experimental Treatment 1 Intervention

Every patient will receive a lung ultrasound prior to each scheduled bronchoscopy until the study stops.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Ultrasound as a Tool to Evaluate Pulmonary Disease in Cystic Fibrosis. Peixoto, AO., Marson, FA., Dertkigil, SS., et al.[2020]

Lung ultrasound proved to be a crucial diagnostic tool in a case of pneumonia, successfully identifying lung injuries that other methods could not, highlighting its value in critically ill patients.

The report introduces a new ultrasound feature that may indicate pulmonary gangrene, suggesting that lung ultrasound could enhance the diagnosis and potentially improve the management of this rare condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

B-Mode Ultrasound Findings in a Patient With Suspected Pulmonary Gangrene. Echivard, M., Lichtenstein, DA., Lala, A., et al.[2021]

A training program involving 25 supervised lung ultrasound examinations enables trainees, including residents and critical care physicians, to achieve basic competence in classifying lung conditions in critically ill patients, with 80% accuracy in lung region classification after training.

The training significantly reduced the time taken for ultrasound examinations, from an average of 19 minutes to 12 minutes for trainees, demonstrating improved efficiency alongside skill acquisition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung Ultrasound in Emergency and Critically Ill Patients: Number of Supervised Exams to Reach Basic Competence. Arbelot, C., Dexheimer Neto, FL., Gao, Y., et al.[2020]

Lung ultrasound proved to be a feasible and effective tool for assessing lung injury in critically ill COVID-19 patients, with a high assessment rate of 96% across 1802 quadrants evaluated in a study of 156 patients.

The lung ultrasound score was significantly correlated with oxygen saturation levels and was associated with mortality, indicating its potential as a valuable prognostic tool in low-income settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of lung injury severity using ultrasound in critically ill COVID-19 patients in resource limited settings. Beye, SA., Diallo, B., Keita, M., et al.[2023]

Lung ultrasound significantly impacts clinical decision-making, changing diagnoses in about 33% of patients in the emergency department (ED) and 44% in the intensive care unit (ICU).

It also alters management strategies in approximately 48% of patients in the ED, 42% in the ICU, and 48% in the general ward (GW), with most changes being non-invasive, highlighting its effectiveness as a diagnostic tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of lung ultrasound on clinical-decision making across departments: a systematic review. Heldeweg, MLA., Vermue, L., Kant, M., et al.[2022]

Lung ultrasound is clinically beneficial and has shown diagnostic value comparable to other imaging methods, especially highlighted during the pandemic.

The study emphasizes the need for a stepwise approach to ensure safety while obtaining lung images, recommending specific acoustic output power limits and further research to address knowledge gaps in lung ultrasound safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Best Practice Recommendations for the Safe use of Lung Ultrasound. Wolfram, F., Miller, D., Demi, L., et al.[2023]

Lung ultrasound has become increasingly important in medical settings, especially during the COVID-19 pandemic, due to its ability to provide reliable, bedside assessments without harm to patients.

The review highlights the basic techniques for performing lung ultrasounds and their application in critical care and emergency departments, emphasizing their role in guiding clinical decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung Ultrasound in Critical Care and Emergency Medicine: Clinical Review. Rocca, E., Zanza, C., Longhitano, Y., et al.[2023]

Lung ultrasound is a valuable addition to transthoracic echocardiography for cardiologists, providing quick and effective assessment of pleural effusion and pulmonary congestion with minimal additional imaging time (less than 1 minute).

This method offers superior diagnostic accuracy compared to chest radiographs, is cost-effective, portable, and radiation-free, making it a promising tool for predicting acute heart failure decompensation and guiding treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung Ultrasound for the Cardiologist. Picano, E., Scali, MC., Ciampi, Q., et al.[2019]

Citations

1. Italy pubmed.ncbi.nlm.nih.gov

Combined ultrasound-CT approach to monitor acute exacerbation of interstitial lung disease. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

Lung Ultrasound in the Assessment of Pulmonary Complications After Lung Transplantation. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The Use of Ultrasound as a Tool to Evaluate Pulmonary Disease in Cystic Fibrosis. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

B-Mode Ultrasound Findings in a Patient With Suspected Pulmonary Gangrene. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Lung Ultrasound in Emergency and Critically Ill Patients: Number of Supervised Exams to Reach Basic Competence. [2020]

6. Germany pubmed.ncbi.nlm.nih.gov

Assessment of lung injury severity using ultrasound in critically ill COVID-19 patients in resource limited settings. [2023]

7. Italy pubmed.ncbi.nlm.nih.gov

The impact of lung ultrasound on clinical-decision making across departments: a systematic review. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Best Practice Recommendations for the Safe use of Lung Ultrasound. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Lung Ultrasound in Critical Care and Emergency Medicine: Clinical Review. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Lung Ultrasound for the Cardiologist. [2019]