Pilot Study to Evaluate the Role of EBUS in the Diagnosis of Acute PE in Critically Ill Patients
Enrolling by invitation · Not applicable
Conditions studied: Acute Pulmonary Embolism
In brief
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.
Key facts
- Study ID
- NCT04047784
- Run by
- University of California, Los Angeles
- People needed
- 60
- Starts
- 2019-08-12
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-05-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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:
- Enrollment for the pulmonary vascular mapping substudy will be based on the following inclusion and exclusion criteria:
- Inclusion criteria:
- 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.
- 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.
Where it is running
- Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
- UCLA Medical Center, Santa Monica — Santa Monica, California, United States
Full record on ClinicalTrials.gov
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