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

Completed

• Conditions: Heart Failure
• Interventions: Device: Indicor; Device: Caretaker

• Registration Number: NCT04665011
• Lead Sponsor: Vixiar Medical, Inc.

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-12-08
• Study First Submitted QC: 2020-12-10
• Study First Posted: 2020-12-11
• Study Start: 2020-12-14
• Primary Completion: 2021-01-28
• Study Completion: 2021-01-28
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-11
• Last Update Posted: 2021-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Clinically stable adults, including heart failure patients visiting an outpatient clinic	Caretaker	Observational to compare simultaneous pulse tracings from PPG and non-invasive blood pressure monitors in capturing the pulse responses to a Valsalva maneuver.
Clinically stable adults, including heart failure patients visiting an outpatient clinic	Indicor	Observational to compare simultaneous pulse tracings from PPG and non-invasive blood pressure monitors in capturing the pulse responses to a Valsalva maneuver.

Primary Outcome Measures

Name	Time	Method
pulse amplitude ratio	5 minutes	The correlation between PPG-based and non-invasive blood pressure pulse amplitude ratio during a Valsalva maneuver.

Secondary Outcome Measures

Name	Time	Method
Phases of valsalva pulse response	5 minuntes	The agreement between PPG-based and non-invasive blood pressure pulse tracings during a Valsalva maneuver.

Trial Locations

Locations (1)

Fort Norfolk Cardiology Associates; 🇺🇸 Norfolk, Virginia, United States