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Completed

NCT Number: NCT04665011

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fort Norfolk Cardiology Associates

Norfolk, Virginia, 23510, United States

About this study

With both a photoplethysmography (PPG; Indicor, Vixiar Medical,. Baltimore, MD) and non-invasive blood pressure (Caretaker, Caretaker Medical, Charlottesville, VA) sensors in place on the index and middle fingers, respectively, each patient will be asked to perform three mild, 10-sec Valsalva maneuvers with at least 45 seconds between. Pulse recordings will be collected from each device to compare phases of the Valsalva pulse response including pulse amplitude changes and baseline movement. The primary outcome is the correlation between pulse amplitude ratios for the pulse at the end of the Valsalva to an average baseline pulse.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinically stable adults, including heart failure patients visiting an outpatient clinic

Exclusion criteria

  • Atrial flutter or atrial fibrillation with an irregular ventricular response
  • Significant atrial or ventricular ectopy
  • History of paradoxical emboli
  • Hypertrophic obstructive cardiomyopathy
  • Known intracardiac shunt
  • Known severe aortic valve stenosis
  • Known severe mitral valve stenosis
  • History of embolic CVA
  • Myocardial infarction within one week of intended Indicor testing
  • Uncontrolled hypertension (systolic BP >160mmHg or diastolic BP>100mmHg)
  • Hypotension (systolic BP <90mmHg)
  • Symptomatic bradycardia
  • Known cholesterol emboli
  • Poor left ventricular function with left ventricular thrombus
  • Unstable angina
  • Significant aortic valvular disease
  • Patients weighing less than 40kg

Treatment and study plan

Indicor

Device

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

Caretaker

Device

non-invasive blood pressure monitor

Primary outcomes

  1. pulse amplitude ratio

    Time frame: 5 minutes

    The correlation between PPG-based and non-invasive blood pressure pulse amplitude ratio during a Valsalva maneuver.

Secondary outcomes

  1. Phases of valsalva pulse response

    Time frame: 5 minuntes

    The agreement between PPG-based and non-invasive blood pressure pulse tracings during a Valsalva maneuver.

Sponsors and collaborators

Lead sponsor

Vixiar Medical, Inc.

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 11, 2020
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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