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Procedure

EBUS for Pulmonary Embolism (VEBUS Trial)

N/A

Waitlist Available

Led By Colleen L Channick, M.D.

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Patient ≥ 18 years of age.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is a prospective, single center study evaluating the role of endobronchial ultrasound in the diagnosis of acute central pulmonary embolism in critically ill patients who cannot undergo a computed tomography angiogram.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of EBUS aren't listed here, common ones from similar procedures may include sore throat, coughing, shortness of breath, bleeding at the biopsy site, and infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess sensitivity and specificity of EBUS to visualize or exclude PE by its ability to identify a clot.

Assess sensitivity and specificity of EBUS to visualize or exclude PE by its ability to identify flow around clot(s) present.

Assess sensitivity and specificity of EBUS to visualize or exclude PE compared to the chest CT.

+4 more

Secondary study objectives

Other airway finding(s)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 2Eligibility criteria met