What this study is
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.
What's being tested
- Endobronchial ultrasound (EBUS)
Intervention · 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 details
- Official title
- Pilot Study to Evaluate the Role of Endobronchial Ultrasound (EBUS) in the Diagnosis of Acute Pulmonary Embolism in Critically Ill Patients
- Sponsor
- University of California, Los Angeles
- Conditions
- Acute Pulmonary Embolism
- Enrolling
- 60 people
- Starts
- 2019-08-12
- Est. completion
- 2028-12-31
- Design
- Open-label, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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.
- 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.
You can't join 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: 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.
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openRonald Reagan UCLA Medical Center
Los Angeles, California, United States
UCLA Medical Center, Santa Monica
Santa Monica, California, United States
Study team
Sponsor
University of California, Los Angeles
Study ID IRB# 19-000295
Principal investigator
Colleen L Channick, M.D.
University of California, Los Angeles
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.