Validation of Ejection Fraction and Cardiac Output Using Biostrap Wristband

NCT ID: NCT05279066

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2022-07-15

Brief 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.

Detailed Description

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.

Conditions

Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients scheduled to undergo an elective cardiac ultrasound

All cardiac patients undergoing an elective cardiac ultrasound as an outpatient at UCLA may be asked to participate in the study. The investigators will identify eligible patients from their medical record. If interested, patients will be consented prior to their scheduled ultrasound.

Biostrap Wristband

Intervention Type: DEVICE

The Biostrap Wristband device is a non-invasive optical sensor that monitors changes in arterial pulse volume using Photoplethysmography (PPG). PPG is frequently used in wearable sensors to detect heart rate as well as other metrics such as heart rate variability (HRV) and respiratory rate. The raw biosignals recorded by the wristband device will be further processed to estimate the ejection fraction and cardiac output.

Patients with a pulmonary arterial catheterization scheduled or completed

All patients hospitalized in the cardiac ICU at UCLA with a pulmonary arterial catheterization scheduled or completed may be asked to participate in the study. The investigators will identify eligible patients from their medical record. If interested, patients will be consented during their hospital stay.

Biostrap Wristband

Intervention Type: DEVICE

The Biostrap Wristband device is a non-invasive optical sensor that monitors changes in arterial pulse volume using Photoplethysmography (PPG). PPG is frequently used in wearable sensors to detect heart rate as well as other metrics such as heart rate variability (HRV) and respiratory rate. The raw biosignals recorded by the wristband device will be further processed to estimate the ejection fraction and cardiac output.

Interventions

Biostrap Wristband

The Biostrap Wristband device is a non-invasive optical sensor that monitors changes in arterial pulse volume using Photoplethysmography (PPG). PPG is frequently used in wearable sensors to detect heart rate as well as other metrics such as heart rate variability (HRV) and respiratory rate. The raw biosignals recorded by the wristband device will be further processed to estimate the ejection fraction and cardiac output.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Ali Nsair, MD

Associate Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Suzan Khalil

Role: CONTACT

skhalil@mednet.ucla.edu

3102676957

Facility Contacts

Suzan Khalil, MD

Role: primary

skhalil@mednet.ucla.edu

310-267-6957

Other Identifiers

21-001030

Identifier Type: -

Identifier Source: org_study_id