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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04665011
• Other study ID #: PROT 000054
• Status: Completed
• Start date: December 14, 2020
• Est. completion date: January 28, 2021

Study information

• Verified date: March 2021
• Source: Vixiar Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: January 28, 2021
• Est. primary completion date: January 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Indicor
A simple, non-invasive tool to report pulse response to a Valsalva maneuver
• Caretaker
non-invasive blood pressure monitor

Locations

Country	Name	City	State
United States	Fort Norfolk Cardiology Associates	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Vixiar Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pulse amplitude ratio	The correlation between PPG-based and non-invasive blood pressure pulse amplitude ratio during a Valsalva maneuver.	5 minutes
Secondary	Phases of valsalva pulse response	The agreement between PPG-based and non-invasive blood pressure pulse tracings during a Valsalva maneuver.	5 minuntes