EBUS for Pulmonary Embolism
(VEBUS Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

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

Trial Summary

What is the purpose of this trial?

Acute pulmonary embolism (PE) in critically ill patients is common and often life threatening. The diagnosis of acute PE is often entertained in intensive care unit patients who develop unexplained hypotension or hypoxemia. Obtaining diagnostic confirmation of acute PE with a contrast-enhanced computed tomography of the chest (CT angiogram) may be difficult as patients are often too unstable for transport to the CT scanner or have renal insufficiency limiting the ability to receive intravenous contrast agents. Making or excluding the diagnosis of acute PE in these patients is critically important, as hemodynamic instability or right heart dysfunction, if due to PE, puts patients in the massive or submassive category and increased mortality risk. More aggressive therapies such as thrombolysis, extracorporeal membrane oxygenation or surgical embolectomy are often entertained. The investigators have previously described a case where endobronchial ultrasound (EBUS) was employed in the diagnostic algorithm of suspected acute PE and significantly affected treatment recommendations. The investigators believe that, in these patients, use of EBUS to assess for thrombotic occlusion of the central pulmonary vasculature can fill a critical gap in the decision tree for management of these patients. EBUS has become part of the diagnostic approach in a number of clinical situations, including the workup and staging of suspected malignancy, unexplained lymphadenopathy, and diagnosis of mediastinal and parabronchial masses. There is strong evidence that EBUS is equivalent to mediastinoscopy in the mediastinal staging of lung cancer. The number of physicians skilled and experienced in performance of EBUS has increased dramatically, and training in the procedure is frequently obtained in a pulmonary fellowship. To our knowledge, there have been no prospective studies that investigate the use of EBUS as a tool for the diagnosis of acute central pulmonary embolism in critically ill patients where obtaining diagnostic confirmation of this diagnosis with a contrast-enhanced computed tomography of the chest is not safe or feasible.

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 data supports the effectiveness of the treatment Endobronchial ultrasound (EBUS) for Pulmonary Embolism?

EBUS has been shown to help identify pulmonary embolism (PE) by detecting blockages in the lung's blood vessels, and it can be used alongside other imaging methods like CT scans to confirm PE diagnosis. It has also been used to guide treatment by delivering medication directly to the affected area, potentially reducing the risk of bleeding.¹ ² ³ ⁴ ⁵

How does the treatment Endobronchial ultrasound (EBUS) differ from other treatments for pulmonary embolism?

Endobronchial ultrasound (EBUS) is unique because it is primarily a diagnostic tool rather than a treatment for pulmonary embolism. It allows doctors to visualize the central pulmonary arteries and detect blood clots, which can be particularly useful in patients with lung cancer. Unlike standard treatments that focus on dissolving or removing clots, EBUS helps in diagnosing and confirming the presence of clots during procedures for other conditions.¹ ⁴ ⁵ ⁶ ⁷

Research Team

Colleen L Channick, M.D.

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Patients undergoing standard of care clinical bronchoscopyExperimental Treatment1 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 PatientsExperimental Treatment1 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 EBUSActive Control1 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.