Status:
ENROLLING_BY_INVITATION
Pilot Study to Evaluate the Role of EBUS in the Diagnosis of Acute PE in Critically Ill Patients
Lead Sponsor:
University of California, Los Angeles
Conditions:
Acute Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
NA
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 hy...
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 subjec...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04047784
Start Date
August 12 2019
End Date
December 31 2026
Last Update
April 30 2025
Active Locations (2)
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1
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
2
UCLA Medical Center, Santa Monica
Santa Monica, California, United States, 90404