Pilot Study to Evaluate the Role of EBUS in the Diagnosis of Acute PE in Critically Ill Patients

NCT04047784 | Enrolling By Invitation FDA Device

• 1 other identifier: IRB# 19-000295
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Acute Pulmonary Embolism

Keywords

EBUS; Acute Pulmonary Embolism; Endobronchial Ultrasound; Pilot

Outcome Measures

Primary Outcomes (7)

• CT angiogram results (if obtained)

  For patients who have had a chest CT for suspected PE, the investigators will obtain a copy of the participant's chest CT for suspected PE report.

  2 years

• Patient treatment

  For patients who are unable to have a CT, the investigators will not be able to determine true efficacy, but will report the number of positive and negative studies. Patient treatment will be reported as: * Catheter Directed Lysis * Heparin Drip * Surgical Embolectomy * Thrombolysis * No Treatment for Pulmonary Embolism (PE)

  2 years

• Patient outcome

  For patients who are unable to have a CT, the investigators will not be able to determine true efficacy, but follow these patients for outcome and subsequent definitive diagnosis of venous thromboembolism. Subsequent patient outcome will be reported as: * Alive * Extended hospitalization * Intervention to prevent impairment or damage * Life-threatening condition * Disability * Death

  2 years

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

  Ability for EBUS will be reported by its ability to identify each major branch and reporting what branched not identified as: * Main Pulmonary Artery (MPA) * Right Pulmonary Artery (RPA) * Truncus Anterior (TA) or Ascending Branch * Right Interlobar Artery or Descending Branch * Right Basal Trunk * Left Pulmonary Artery (LPA) * Left Interlobar Artery * Left Basal Trunk * Other

  2 years

• Report any complications

  Complications during or after the procedure will be reported as: * Airway Bleeding * Airway Injury * Hypotension as defined by \< 65 mmHg or need to escalate vasopressors * Hypoxia as defined by \< 90% * Other * None

  2 years

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

  Ability for EBUS will be reported by its ability to identify a clot and reporting the location of the clot as: * Main Pulmonary Artery (MPA) * Right Pulmonary Artery (RPA) * Truncus Anterior (TA) or Ascending Branch * Right Interlobar Artery or Descending Branch * Right Basal Trunk * Left Pulmonary Artery (LPA) * Left Interlobar Artery * Left Basal Trunk * Other

  2 years

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

  Ability for EBUS will be reported by its ability to identify flow around clot(s) present and reporting the location of the flow around clot(s) present as: * Main Pulmonary Artery (MPA) * Right Pulmonary Artery (RPA) * Truncus Anterior (TA) or Ascending Branch * Right Interlobar Artery or Descending Branch * Right Basal Trunk * Left Pulmonary Artery (LPA) * Left Interlobar Artery * Left Basal Trunk * Other

  2 years

Secondary Outcomes (1)

• Other airway finding(s)

  2 years

Study Arms (3)

Critically Ill Patients

EXPERIMENTAL

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.

Device: Endobronchial ultrasound (EBUS)

Patients undergoing standard of care clinical bronchoscopy

EXPERIMENTAL

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

Device: Endobronchial ultrasound (EBUS)

Previously recorded patient media from standard of care clinical bronchoscopy with EBUS

NO 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.

Interventions

Endobronchial ultrasound (EBUS) DEVICE

An Olympus EBUS bronchoscope will be used for all endobronchial ultrasound examinations. This scope has a 6.9 mm outer diameter, a 2.7 mm working channel and 30-degree oblique forward-viewing optics. A 12 MHz linear ultrasound transducer with a maximum penetration of 50 mm will be linked to a processor (Olympus EU-ME2) that allows an integrated power Doppler mode to visualize the vascular blood flow. Bronchoscopy will be introduced through the adaptor connected to the endotracheal tube, in patients who are already under general anesthesia and on mechanical ventilation. The bronchoscope will be advanced into the airways and endobronchial ultrasound of the main pulmonary artery (PA) and lobar branches will be performed in a standardized fashion. At the completion of the imaging the EBUS bronchoscope will be withdrawn.

Critically Ill Patients; Patients undergoing standard of care clinical bronchoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient ≥ 18 years of age.
• The patient or patient's surrogate must understand and sign informed consent form (ICF).
• 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.

You may not qualify if:

• Patient does not meet the requirements to undergo clinical bronchoscopy, as determined by the treating physician.
• Endotracheal tube size less than 8.0 mm.
• Contraindications to lidocaine.
• Pulmonary Vascular Mapping Substudy:
• Patient ≥ 18 years of age.
• The patient or patient's surrogate must understand and sign informed consent form (ICF).
• Intubated patients undergoing clinical bronchoscopy, as determined by the treating physician.
• Patient does not meet the requirements to undergo clinical bronchoscopy, as determined by the treating physician.
• Endotracheal tube size less than 8.0 mm.
• Contraindications to lidocaine.
• Retrospective Chart Review:
• Of the 60 total subjects enrolled in the study, media including images and videos that are previously recorded for 20 patients who underwent a clinical bronchoscopy with EBUS as a part of their standard of care will also be available to our research team without consent from the patient to help supplement the data we obtain from the 20 subjects that are enrolled in the pulmonary vascular mapping substudy.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (2)

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

UCLA Medical Center, Santa Monica

Santa Monica, California, 90404, United States

Location

Related Publications (7)

• Tapson VF. Acute pulmonary embolism. N Engl J Med. 2008 Mar 6;358(10):1037-52. doi: 10.1056/NEJMra072753. No abstract available.

  PMID: 18322285 RESULT

• Stein PD, Henry JW. Prevalence of acute pulmonary embolism among patients in a general hospital and at autopsy. Chest. 1995 Oct;108(4):978-81. doi: 10.1378/chest.108.4.978.

  PMID: 7555172 RESULT

• Aumiller J, Herth FJ, Krasnik M, Eberhardt R. Endobronchial ultrasound for detecting central pulmonary emboli: a pilot study. Respiration. 2009;77(3):298-302. doi: 10.1159/000183197. Epub 2008 Dec 9.

  PMID: 19065053 RESULT

• Ernst A, Anantham D, Eberhardt R, Krasnik M, Herth FJ. Diagnosis of mediastinal adenopathy-real-time endobronchial ultrasound guided needle aspiration versus mediastinoscopy. J Thorac Oncol. 2008 Jun;3(6):577-82. doi: 10.1097/JTO.0b013e3181753b5e.

  PMID: 18520794 RESULT

• Yasufuku K, Pierre A, Darling G, de Perrot M, Waddell T, Johnston M, da Cunha Santos G, Geddie W, Boerner S, Le LW, Keshavjee S. A prospective controlled trial of endobronchial ultrasound-guided transbronchial needle aspiration compared with mediastinoscopy for mediastinal lymph node staging of lung cancer. J Thorac Cardiovasc Surg. 2011 Dec;142(6):1393-400.e1. doi: 10.1016/j.jtcvs.2011.08.037. Epub 2011 Oct 2.

  PMID: 21963329 RESULT

• Tanner NT, Pastis NJ, Silvestri GA. Training for linear endobronchial ultrasound among US pulmonary/critical care fellowships: a survey of fellowship directors. Chest. 2013 Feb 1;143(2):423-428. doi: 10.1378/chest.12-0212.

  PMID: 22878834 RESULT

• Torbicki A, Galie N, Covezzoli A, Rossi E, De Rosa M, Goldhaber SZ; ICOPER Study Group. Right heart thrombi in pulmonary embolism: results from the International Cooperative Pulmonary Embolism Registry. J Am Coll Cardiol. 2003 Jun 18;41(12):2245-51. doi: 10.1016/s0735-1097(03)00479-0.

  PMID: 12821255 RESULT

Related Links

• Pulmonary Artery Anatomy

Study Officials

• Colleen L Channick, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Medicine

Model Details: This is a single center, pilot study to evaluate critically ill patients diagnosed with acute pulmonary embolism using endobronchial ultrasound (EBUS). The investigators anticipate to enroll 60 subjects at Ronald Reagan UCLA Medical Center and UCLA Medical Center, Santa Monica. The enrolled subjects will be imaged using the flexible bronchoscopy with EBUS.

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: August 7, 2019
• Study Start: August 12, 2019
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)