Acute Pulmonary EmbolismVEBUSNCT04047784
Pilot Study to Evaluate the Role of EBUS in the Diagnosis of Acute PE in Critically Ill Patients
A study testing Endobronchial ultrasound (EBUS) in people with Acute Pulmonary Embolism, run by University of California, Los Angeles at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pulmonary Embolism
- What is being tested?
- Endobronchial ultrasound (EBUS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Aug 2019to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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:
- Enrollment for the pulmonary vascular mapping substudy will be based on the following inclusion and exclusion criteria:
- Patient does not meet the requirements to undergo clinical bronchoscopy, as determined by the treating physician.
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
UCLA Medical Center, Santa Monica
Santa Monica, California, 90404
About this study
Official title: Pilot Study to Evaluate the Role of Endobronchial Ultrasound (EBUS) in the Diagnosis of Acute Pulmonary Embolism in Critically Ill Patients
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.
Read the detailed description
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 20 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.
After informed consent is obtained, the following procedure will be performed:
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 as follow:
Advance the bronchoscopy into the right main bronchus distally to the level of the right lower lobe, between 12 and 3 o'clock position where the interlobar artery of the PA is seen. Then the scope will be pulled back slowly, turning counterclockwise, following the course of the PA on the medial wall of the right bronchial tree until the level of the carina, where the right main PA and the PA trunk are seen. The scope is then turned to the right again, towards 3 o'clock following the right upper lobe bronchus to examine the upper lobar artery. The scope is then advanced into the left main bronchus, towards 9 o'clock to examine the upper lobar artery, then advanced distally to the left lower lobe bronchus to examine the interlobar artery. At the completion of the imaging the EBUS bronchoscope will be withdrawn.
Ultrasound images and video will be stored to the machine and visualized thrombi will be marked.
For patients who have had a chest CT for suspected PE, the investigators will assess sensitivity and specificity of EBUS to visualize or exclude PE. 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 and follow these patients for outcome and subsequent definitive diagnosis of venous thromboembolism.
As this is a pilot study looking at the feasibility of EBUS for diagnosing acute pulmonary embolism, study personnel performing the EBUS will not be blinded to the clinical diagnosis and the management of the subject. A brief report of the procedure results will be uploaded in the patient's medical record. Any clinically relevant findings from the EBUS will be communicated to the subject's treating team. Regardless of the findings, a note stating that the EBUS technique is not yet established for evaluating acute pulmonary embolism in critically ill patients will be emphasized in order to prevent any bias in the patient's clinical care.
Pulmonary Vascular Mapping Substudy:
Of the 60 total subjects enrolled in the study, approximately 20 subjects under the criteria below will be enrolled at Ronald Reagan UCLA Medical Center and UCLA Medical Center, Santa Monica undergoing clinical bronchoscopy as a part of their standard of care. The enrolled subjects will be imaged using the flexible bronchoscopy with EBUS.
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.
- Conditions
- Acute Pulmonary Embolism
- Being tested
- Endobronchial ultrasound (EBUS)
- Keywords
- EBUS, Acute Pulmonary Embolism, Endobronchial Ultrasound, Pilot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 2 years
Secondary outcomes (1)
Other airway finding(s)
Other airway finding(s) will be reported as:
- Mucus
- Blood
- Other
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start12 Aug 2019
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colleen Channick, MD, University of California, Los Angeles
- Investigators
- Colleen L Channick, M.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047784
- Sponsor's protocol ID
- IRB# 19-000295
- Acronym
- VEBUS
- Status last verified
- Apr 2026
- First submitted
- 31 May 2019
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tapson VF. Acute pulmonary embolism. N Engl J Med. 2008 Mar 6;358(10):1037-52. doi: 10.1056/NEJMra072753. No abstract available.
PubMed 18322285Stein 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.
PubMed 7555172Aumiller 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.
PubMed 19065053Ernst 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.
PubMed 18520794Yasufuku 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.
PubMed 21963329Tanner 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.
PubMed 22878834Torbicki 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.
PubMed 12821255
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Role of Endobronchial Ultrasound (EBUS) in the Diagnosis of Acute Pulmonary Embolism in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT04047784
- Acronym / sponsor ID
- VEBUS / IRB# 19-000295
- Conditions
- Acute Pulmonary Embolism
- Keywords
- EBUS, Acute Pulmonary Embolism, Endobronchial Ultrasound, Pilot
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 20 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.
After informed consent is obtained, the following procedure will be performed:
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 as follow:
Advance the bronchoscopy into the right main bronchus distally to the level of the right lower lobe, between 12 and 3 o'clock position where the interlobar artery of the PA is seen. Then the scope will be pulled back slowly, turning counterclockwise, following the course of the PA on the medial wall of the right bronchial tree until the level of the carina, where the right main PA and the PA trunk are seen. The scope is then turned to the right again, towards 3 o'clock following the right upper lobe bronchus to examine the upper lobar artery. The scope is then advanced into the left main bronchus, towards 9 o'clock to examine the upper lobar artery, then advanced distally to the left lower lobe bronchus to examine the interlobar artery. At the completion of the imaging the EBUS bronchoscope will be withdrawn.
Ultrasound images and video will be stored to the machine and visualized thrombi will be marked.
For patients who have had a chest CT for suspected PE, the investigators will assess sensitivity and specificity of EBUS to visualize or exclude PE. 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 and follow these patients for outcome and subsequent definitive diagnosis of venous thromboembolism.
As this is a pilot study looking at the feasibility of EBUS for diagnosing acute pulmonary embolism, study personnel performing the EBUS will not be blinded to the clinical diagnosis and the management of the subject. A brief report of the procedure results will be uploaded in the patient's medical record. Any clinically relevant findings from the EBUS will be communicated to the subject's treating team. Regardless of the findings, a note stating that the EBUS technique is not yet established for evaluating acute pulmonary embolism in critically ill patients will be emphasized in order to prevent any bias in the patient's clinical care.
Pulmonary Vascular Mapping Substudy:
Of the 60 total subjects enrolled in the study, approximately 20 subjects under the criteria below will be enrolled at Ronald Reagan UCLA Medical Center and UCLA Medical Center, Santa Monica undergoing clinical bronchoscopy as a part of their standard of care. The enrolled subjects will be imaged using the flexible bronchoscopy with EBUS.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Critically Ill Patients | Experimental | Device: Endobronchial ultrasound (EBUS)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. |
| Patients undergoing standard of care clinical bronchoscopy | Experimental | Device: Endobronchial ultrasound (EBUS)Patients undergoing clinical bronchoscopy as a part of their standard of care. The enrolled subjects will be imaged using the flexible bronchoscopy with 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Patient ≥ 18 years of age.
- The patient or patient's surrogate must understand and sign informed consent form (ICF).
Key exclusion criteria (10 listed)
- 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.
- Enrollment for the pulmonary vascular mapping substudy will be based on the following inclusion and exclusion criteria:
- Patient does not meet the requirements to undergo clinical bronchoscopy, as determined by the treating physician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endobronchial ultrasound (EBUS)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. | Device | Critically Ill Patients, Patients undergoing standard of care clinical bronchoscopy |
Primary outcome
CT angiogram results (if obtained)
Time frame: 2 years
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.
Patient treatment
Time frame: 2 years
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)
Patient outcome
Time frame: 2 years
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
Assess sensitivity and specificity of EBUS to visualize or exclude PE compared to the chest CT.
Time frame: 2 years
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
Report any complications
Time frame: 2 years
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
Assess sensitivity and specificity of EBUS to visualize or exclude PE by its ability to identify a clot.
Time frame: 2 years
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
Assess sensitivity and specificity of EBUS to visualize or exclude PE by its ability to identify flow around clot(s) present.
Time frame: 2 years
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
1 secondary outcome
Other airway finding(s)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Results publication: PubMed 18322285Tapson VF. Acute pulmonary embolism. N Engl J Med. 2008 Mar 6;358(10):1037-52. doi: 10.1056/NEJMra072753. No abstract available.
- Results publication: PubMed 7555172Stein 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.
- Results publication: PubMed 19065053Aumiller 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.
- Results publication: PubMed 18520794Ernst 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.
- Results publication: PubMed 21963329Yasufuku 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.
- Results publication: PubMed 22878834Tanner 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.
- Results publication: PubMed 12821255Torbicki 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.
- Pulmonary Artery AnatomyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Colleen L Channick, M.D. principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endobronchial ultrasound (EBUS) in people with Acute Pulmonary Embolism, run by University of California, Los Angeles at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CT angiogram results (if obtained) (time frame: 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04047784, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.