Heart Failure
Conditions
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.
Interventions
Sponsors
Vixiar Medical, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pulse amplitude ratio | 5 minutes | The correlation between PPG-based and non-invasive blood pressure pulse amplitude ratio during a Valsalva maneuver. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phases of valsalva pulse response | 5 minuntes | The agreement between PPG-based and non-invasive blood pressure pulse tracings during a Valsalva maneuver. |
Countries
United States
Outcome results
None listed