Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Ali Nsair, MD (ucla)

Description

Summary

In this study, the investigators will compare the accuracy of the Biostrap wristband, a wearable device with a clinical-grade Photoplethysmography (PPG) sensor, to measure ejection fraction and cardiac output in patients undergoing a cardiac ultrasound and pulmonary arterial catheterization, respectively.

Official Title

A Clinical Validation Study for Measuring Cardiac Output and Ejection Fraction Using a Wrist-worn Device.

Details

This in an introductory clinical study with both cardiac patients undergoing elective cardiac ultrasound and cardiac ICU patients with pulmonary arterial catheters featuring Biostrap wristband. This is a single site, non-blinded, non-randomized study. The wristband is a wearable device that contains a clinical-grade Photoplethysmography (PPG) sensor which will measure parameters quasi-continuously and non-invasively. The device, Biostrap wristband, will measure cardiac ejection fraction (EF) and cardiac output (CO). We will enroll a total of 100 patients: 2 groups of 50. 50 patients undergoing an elective cardiac ultrasound as part of their routine medical care will wear the device for 1-2 hours as an outpatient depending on the duration of the test. 50 hospitalized patients with a scheduled or completed pulmonary arterial catheter inserted as part of their standard medical care will wear the device for 7 days. The investigators will perform a retrospective analysis comparing the accuracy of EF and CO measured by the device in comparison to those from a 'reference device', which is the cardiac ultrasound for ejection fraction and the pulmonary arterial catheter for cardiac output values. Cardiac Ultrasound and pulmonary arterial catheters are standard of care procedures.

Keywords

Heart Failure ejection fraction cardiac output Biostrap Wristband

Eligibility

You can join if…

Open to people ages 18 years and up

  1. ≥ 18 years of age.
  2. Subjects who are undergoing elective cardiac ultrasound as an outpatient for group 1 or are scheduled for/completed a pilmonary arterial catheterization for group 2.
  3. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

You CAN'T join if...

  1. Subject is unable or unwilling to wear the wristband for the required duration.

Location

  • Ronald Reagan UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at University of California Health

  • Ali Nsair, MD (ucla)
    HS Associate Clinical Professor, Medicine. Authored (or co-authored) 50 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT05279066
Study Type
Observational
Participants
Expecting 100 study participants
Last Updated