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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Indicor; Device: Caretaker

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 Type: Observational
• Enrollment (Actual): 121

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Norfolk, Virginia, United States, 23510
      • Fort Norfolk Cardiology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study sample has a focus on heart failure patients as this is a clinical target population for the clinical use of the Indicor. However, non-heart failure subjects may be needed to ensure that a range of normal outcome values are included in the analysis. Therefore, at least 70% of the enrollment is intended to be derived from a cardiology practice office, and up to 30% of the enrollment may be non-patient participants.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Indicor; A simple, non-invasive tool to report pulse response to a Valsalva maneuver; Device: Caretaker; non-invasive blood pressure monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pulse amplitude ratio	The correlation between PPG-based and non-invasive blood pressure pulse amplitude ratio during a Valsalva maneuver.	5 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vixiar Medical, Inc.
• Investigators: Principal Investigator: Keith H. Newby, M.D., Fort Norfolk Cardiology Associates

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2020
• Primary Completion (Actual): January 28, 2021
• Study Completion (Actual): January 28, 2021

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 10, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): March 16, 2021
• Last Update Submitted That Met QC Criteria: March 11, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: PROT 000054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No