EBUS for Pulmonary Embolism

(VEBUS Trial)

Enrolling by invitation at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Bronchoscopy requirements, Tube size, Lidocaine

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to diagnose acute pulmonary embolism (a serious blockage in the lungs) in critically ill patients. Typically, a CT scan diagnoses this condition, but some patients are too sick for this test. Instead, the study tests endobronchial ultrasound (EBUS), which uses sound waves to examine the lungs, as a potential safe alternative. Suitable candidates for this trial include those intubated in the ICU with suspected or confirmed pulmonary embolism. As an unphased trial, it offers the chance to contribute to innovative diagnostic methods that could benefit future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this method is safe for diagnosing acute pulmonary embolism?

Research has shown that endobronchial ultrasound (EBUS) is often used safely in various medical situations. Studies have found that EBUS can effectively help diagnose lung problems, including pulmonary embolism (PE).

For example, one study discovered that using EBUS to guide certain treatments for PE was safe and could accurately target the clots. Another study demonstrated that EBUS is a good option for diagnosing PE when other methods, like CT scans, aren't available.

Overall, EBUS is generally well-tolerated, and its use in medicine is increasing. Many doctors learn to use EBUS during their training, which helps ensure its safe and effective application. So far, there have been no major reports of serious side effects directly linked to the procedure itself. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for pulmonary embolism, like anticoagulants or thrombolytics, focus on breaking down clots or preventing new ones from forming. However, researchers are excited about endobronchial ultrasound (EBUS) because it offers a unique diagnostic approach. EBUS uses a flexible bronchoscope equipped with ultrasound to produce real-time images of the lungs and surrounding areas, helping doctors visualize clots directly and potentially diagnose pulmonary embolisms more accurately and quickly. This method could be especially beneficial for critically ill patients in intensive care, where rapid and precise diagnosis is crucial. By improving diagnostic precision, EBUS could lead to more targeted and effective treatment strategies for pulmonary embolism.

What evidence suggests that EBUS is effective for diagnosing acute pulmonary embolism?

Research has shown that endobronchial ultrasound (EBUS) effectively detects blood clots in the lungs, known as pulmonary embolism (PE). Studies have found EBUS to be up to 96% accurate, and sometimes even 100% accurate. EBUS matches the reliability of other well-known methods for diagnosing lung issues, such as cancer. Its high accuracy in detecting PE means it is almost always correct. This trial will evaluate EBUS in various patient groups, including critically ill patients in the ICU and those undergoing standard clinical bronchoscopy. These findings suggest that EBUS could be highly useful for diagnosing PE in seriously ill patients who cannot safely undergo a CT scan. ^{2 4 6 7 8}

Who Is on the Research Team?

Colleen L Channick, M.D.

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for adults over 18 in the ICU suspected of having or confirmed with acute pulmonary embolism, who are intubated and can't be safely moved for a CT scan. They must understand and sign a consent form. It's not for those with an endotracheal tube size under 8.0 mm, contraindications to lidocaine, or unsuitable for bronchoscopy.

Inclusion Criteria

The patient or patient's surrogate must understand and sign informed consent form (ICF).

I am on a breathing machine in the ICU, suspected or diagnosed with a lung clot.

I am intubated and my doctor has decided I need a bronchoscopy.

Exclusion Criteria

My doctor says I can't have a bronchoscopy.

You have a breathing tube smaller than 8.0 mm.

You should not use lidocaine for medical reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endobronchial ultrasound (EBUS) using a bronchoscope to diagnose acute pulmonary embolism

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the EBUS procedure

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Endobronchial ultrasound (EBUS)

Trial Overview The study tests if Endobronchial ultrasound (EBUS) can diagnose acute central pulmonary embolism in critically ill patients when a CT scan isn't safe or possible. This pilot study aims to see if EBUS could help decide on urgent treatments without moving unstable patients.

How Is the Trial Designed?

Group I: Patients undergoing standard of care clinical bronchoscopy Experimental Treatment 1 Intervention

Patients undergoing clinical bronchoscopy as a part of their standard of care. The enrolled subjects will be imaged using the flexible bronchoscopy with EBUS.

Group II: Critically Ill Patients Experimental Treatment 1 Intervention

Intubated patients in the intensive care unit (ICU) where there is a clinical concern for acute pulmonary embolism or a confirmed diagnosis for acute pulmonary embolism. The enrolled subjects will be imaged using the flexible bronchoscopy with EBUS.

Group III: Previously recorded patient media from standard of care clinical bronchoscopy with EBUS Active Control 1 Intervention

Patients who underwent a standard of care clinical bronchoscopy with EBUS previously. Information and media including images and videos that were previously recorded for patients who underwent a standard of care clinical bronchoscopy with EBUS will be available to the study team.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Citations

1. karger.com karger.com/res/article/102/8/601/854790/Endobronchial-Ultrasound-for-the-Screening-of

Endobronchial Ultrasound for the Screening of Pulmonary ... The positive predictive value of EBUS for PE was 100%. Conclusion: EBUS for PE screening seems feasible and with limited time use. The PPV of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10795244/

The evolution of endobronchial ultrasound usage in modern era A pilot study showed that EBUS has a detection accuracy of 96% in identifying PE, and this accuracy increases to 100% when exclusively focusing ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666250723003073

Assessment of effectiveness and safety of thrombolytic ... Endobronchial ultrasound–guided transbronchial needle injection (EBUS-TBNI) may effectively treat acute pulmonary embolisms (PEs).

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04047784

Pilot Study to Evaluate the Role of EBUS in the Diagnosis ... This is a single center, pilot study to evaluate critically ill patients diagnosed with acute pulmonary embolism using endobronchial ultrasound (EBUS). The ...

5. publications.ersnet.org publications.ersnet.org/content/erj/60/suppl66/1746

Systematic evaluation of the pulmonary arteries during ... Conclusion: Scanning the pulmonary arteries during EBUS is barely time consuming. PE was only found in 2% despite a large number of advanced lung cancers. Both ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37498007/

Endobronchial Ultrasound for the Screening of Pulmonary ... The aim of this study was to establish if screening during EBUS for PE in patients with suspected lung cancer is feasible and if positive findings are ...

7. thorax.bmj.com thorax.bmj.com/content/early/2025/02/26/thorax-2024-221866.full

Pulmonary embolism on endobronchial ultrasound The patient was managed with standard quadruple therapy for heart failure and demonstrated stable vital signs, no desaturation on the 6 min ...

8. journal.chestnet.org journal.chestnet.org/article/S0012-3692(24)04344-7/fulltext

USE OF ENDOBRONCHIAL ULTRASOUND TO CONFIRM ... EBUS can be effectively used as an alternative modality to diagnose PE in patients who are not candidates for CTA, or those in whom CTA is inconclusive.