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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

121 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-14

Study Completion Date

2021-01-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

Observational to compare simultaneous pulse tracings from PPG and non-invasive blood pressure monitors in capturing the pulse responses to a Valsalva maneuver.

Indicor

Intervention Type DEVICE

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

Caretaker

Intervention Type DEVICE

non-invasive blood pressure monitor

Interventions

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Indicor

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

Intervention Type DEVICE

Caretaker

non-invasive blood pressure monitor

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes