Non-Invasive Measurement of Cardiac Output and Stroke Volume in PE

March 16, 2026 updated by: Richard N. Channick, University of California, Los Angeles

Use of Non-invasive Measurement of Cardiac Output and Stroke Volume to Assess Risk and Response to Treatment in Patients With Pulmonary Embolism (PE)

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.

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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 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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • BMI < 20 or BMI > 35.
  • Height less than 120 cm.
  • Diagnosis of atrial fibrillation, moderate to severe aortic or mitral valve insufficiency or stenosis, scleroderma, or end-stage renal disease.
  • Patients on extracorporeal membrane oxygenation (ECMO).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients diagnosed with Pulmonary Embolism
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.
Device: Non-invasive hemodynamic measurements
A patient profile will be set up in the Edwards EV1000 clinical platform by inputting the patient's demographic information. One or two Edwards ClearSight finger cuffs will be placed on the index, middle, and/or ring finger on one hand of the patient. A pressure controller will be secured by a forearm strap where the finger cuffs will be connected to the pressure controller. The pressure controller will be connected to the Edwards EV1000 clinical platform monitor. A heart reference sensor (HRS) will be connected to the pressure controller, a finger cuff, and to the patient at heart level. The Edwards EV1000 clinical platform will calibrate the finger probes, then record measurements for 10-30 seconds every 15 minutes for 12 to 24 hours. If two finger probes are available, measurements will alternate between fingers.
Other Names:
  • Non-invasive blood pressure (NIBP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stroke volume (SV)
Time Frame: 12-24 hours
Stroke Volume (SV) is the volume of blood in millilitres ejected from the each ventricle due to the contraction of the heart muscle which compresses these ventricles.
12-24 hours
stroke volume index (SVI)
Time Frame: 12-24 hours
Stroke Volume Index (SVI) relates SV to body surface area (BSA), thus relating heart performance to the size of the individual. The unit of measurement is millilitres per square metre (ml/m2).
12-24 hours
cardiac output (CO)
Time Frame: 12-24 hours
Cardiac Output (CO) is the amount of blood the heart pumps from each ventricle per minute. It is usually expressed in litres per minute (L/min).
12-24 hours
cardiac index (CI)
Time Frame: 12-24 hours
Cardiac index (CI) is the cardiac output proportional to the body surface area (BSA). The unit of measurement is litres per minute per square metre (L/min/m2).
12-24 hours
systemic vascular resistance (SVR)
Time Frame: 12-24 hours

Systemic vascular resistance (SVR) refers to the resistance to blood flow offered by all of the systemic vasculature, excluding the pulmonary vasculature.

The units for SVR are most commonly expressed as pressure (mmHg) divided by cardiac output (mL/min), or mmHg⋅min⋅mL^-1
12-24 hours
blood pressure (BP)
Time Frame: 12-24 hours

The pressure of the blood in the circulatory system, often measured for diagnosis since it is closely related to the force and rate of the heartbeat and the diameter and elasticity of the arterial walls.

Systolic Blood Pressure in mmHg Diastolic Blood Pressure in mmHg
12-24 hours
heart rate (HR)
Time Frame: 12-24 hours

The number of heartbeats per unit of time, usually per minute.

Measured in beats per minute (BPM)
12-24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Investigators

  • Principal Investigator: Richard N Channick, M.D., University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 15, 2025

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

April 19, 2021

First Submitted That Met QC Criteria

April 19, 2021

First Posted (Actual)

April 22, 2021

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-002033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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