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Validation of Indicor Photoplethysmography (PPG) Valsalva Pulse Response vs Non-invasive Blood Pressure

NCT04665011 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 121

Last updated 2021-03-16

No results posted yet for this study

Summary

This study designed is compare the pulse response to the Valsalva maneuver between a photoplethysmography sensor (PPG) and non-invasive blood pressure sensor for the purpose of validating the PPG methodology in deriving a value for the Valsalva pulse response. The aim is to show that the PPG method captures the same phase responses as the blood pressure monitor and the primary outcome is the correlation between pulse amplitude ratios for the pulse at the end of the Valsalva to an average baseline pulse.

Conditions

Interventions

DEVICE

Indicor

A simple, non-invasive tool to report pulse response to a Valsalva maneuver

DEVICE

Caretaker

non-invasive blood pressure monitor

Sponsors & Collaborators

  • Vixiar Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Keith H. Newby, M.D. · Fort Norfolk Cardiology Associates

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-14
Primary Completion
2021-01-28
Completion
2021-01-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04665011 on ClinicalTrials.gov