Non-Invasive Measurement of Cardiac Output and Stroke Volume in PE
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pulmonary Disease
- Pulmonary Embolism
- Pulmonary Embolism Acute Massive
- Pulmonary Embolism and Thrombosis
- Pulmonary Embolism Subacute Massive
- Pulmonary Embolus/Emboli
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: This is a single center study to evaluate the use of non-invasive measurement of stroke volume and cardiac output to assess risk and response to treatment in patients with acute pulmonary embolism (PE). We anticipate enrolling a total of 40 subjects at Ronald Reagan UCLA Medical Center.Masking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a single center study to evaluate the use of non-invasive measurement of stroke volume and cardiac output to assess risk and response to treatment in patients with acute pulmonary embolism (PE). A total of 40 subjects at Ronald Reagan UCLA Medical Center are anticipated to be enrolled. After...
This is a single center study to evaluate the use of non-invasive measurement of stroke volume and cardiac output to assess risk and response to treatment in patients with acute pulmonary embolism (PE). A total of 40 subjects at Ronald Reagan UCLA Medical Center are anticipated to be enrolled. After informed consent is obtained, the following procedure will be performed: Patients requiring ICU level care with confirmed diagnosis of PE by CT angiogram or EBUS will be connected to a device that measures hemodynamics non-invasively called the Edwards ClearSight system and Edwards EV1000 clinical platform for 12 to 24 hours. The device is a finger probe worn with a supportive forearm strap. Hemodynamic measurements from the finger cuff will be recorded at intervals. After 12 hours, measurements will be taken if patient comfort and compliance allows. Patients will be followed through their hospitalization. Standard of care data will be collected from the medical record including vital signs, cardiac monitor recordings, baseline electrocardiogram, central venous pressure (CVP) if available, ventilator settings and measurements, labs (troponin, d-dimer, lactate, pH, complete blood count, basic metabolic panel, B-type natriuretic peptide (BNP) or N-terminal-pro hormone BNP (NT-proBNP), prothrombin time and international normalized ratio (PT/INR), anti-Xa assay, and partial thromboplastin time (PTT)), imaging, interventions performed, therapies administered, discharge outcome and functional status. As this is a study looking at the feasibility of non-invasive measurement of cardiac output and stroke volume for treating acute pulmonary embolism, study personnel performing the study procedures will not be blinded to the clinical diagnosis and the management of the subject.
Tracking Information
- NCT #
- NCT04855370
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Richard N Channick, M.D. University of California, Los Angeles