Non-Invasive Measurement of Cardiac Output and Stroke Volume in PE
Key facts
- Who runs it
- University of California, Los Angeles
- Where
- Los Angeles, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Started
- 15 Jul 2025
- Ended
- 31 Dec 2025
- Type of study
- Interventional
- Treatments tested
- Non-invasive hemodynamic measurements
- Record updated
- 18 March 2026
- Why it stopped
- Study device no longer available
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Patient ≥ 18 years of age
- The patient must understand and sign informed consent form (ICF)
- Patients requiring intensive care unit (ICU) level care with a confirmed diagnosis of pulmonary embolism (PE) by computed tomography (CT) angiogram or endobronchial ultrasound (EBUS) prior to or within 4 hours of initiation of any PE therapy or intervention
- If a patient already has non-invasive hemodynamic monitoring by the Edwards system or by other systems, such as the Cheetah NICOM system, as part of their standard of care, this patient can still be enrolled. If the patient is already being followed by another system such as NICOM, the Edwards system would be added to it as long as the patient consents
Who cannot take part
- Diagnosis of atrial fibrillation, moderate to severe aortic or mitral valve insufficiency or stenosis, scleroderma, or end-stage renal disease
- BMI < 20 or BMI > 35
- Height less than 120 cm
- Patients on extracorporeal membrane oxygenation (ECMO)
Where in United States
- Ronald Reagan UCLA Medical CenterLos Angeles, United States
About the trial
What the trial wants to find out
Pulmonary embolism impacts over 1 in 1000 adults annually and is the third leading cause of cardiovascular death after heart attack and stroke. The consequence of each PE is widely variable. Physiologically, the morbidity and mortality of PE is ultimately caused by failure of the right ventricle. The acute rise in pulmonary vascular resistance caused by a PE can overwhelm the right ventricle, resulting in a drop in cardiac output and death from failure of the heart to provide vital perfusion. Despite the importance of stroke volume and cardiac output in the current understanding of PE mortality, they are notably absent from risk stratification scores because they historically could only be measured invasively.
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Novel non-invasive methods of estimating stroke volume and associated cardiac output have the potential to revolutionize PE risk stratification and care. Non-invasive blood pressure (NIBP) monitors can even measure stroke volume beat to beat, allowing for continuous evaluation of cardiac function. NIBP systems are typically composed of a finger cuff with an inflatable bladder, pressure sensors, and light sensors. An arterial pulse contour is formed using the volume clamp method of blood pressure measurement combined with calibration and brachial pressure reconstruction algorithms. The stroke volume with each heart beat can be estimated as the area under the systolic portion of the blood pressure curve divided by the afterload. NIBP monitors may improve clinical care of PE because they allow for assessment of dynamic cardiac changes in real time. Detection of worsening stroke volume in acute PE could inform providers of impending cardiac collapse, and improvement of stroke volume may function as a positive prognostic factor or marker of therapeutic success. Use of NIBP monitors during acute PE to identify clinically significant changes in cardiac function may advance both PE prognostication and management.
Our clinical study proposes to monitor hemodynamic parameters including stroke volume in patients with acute pulmonary embolism using non-invasive blood pressure monitors. The relationship between hemodynamic parameters and PE outcomes will be assessed, as well as the changes in hemodynamic parameters with PE intervention. To our knowledge, interval monitoring of stroke volume during acute PE with NIBP monitors has never been reported before.
The group in the trial
- Patients diagnosed with Pulmonary EmbolismTreatment being tested
Patients requiring intensive care unit (ICU) level care with a confirmed diagnosis of pulmonary embolism (PE) by computed tomography (CT) angiogram or endobronchial ultrasound (EBUS) prior to or within 4 hours of initiation of any PE therapy or intervention.
Treatment: Non-invasive hemodynamic measurements
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Use of Non-invasive Measurement of Cardiac Output and Stroke Volume to Assess Risk and Response to Treatment in Patients With Pulmonary Embolism (PE)
- Record updated
- 18 March 2026