Validation of Indicor Photoplethysmography (PPG) Valsalva Pulse Response vs Non-invasive Blood Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- pulse amplitude ratio
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinically stable adults, including heart failure patients visiting an outpatient clinic
排除标准
- •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
结局指标
主要结局
pulse amplitude ratio
时间窗: 5 minutes
The correlation between PPG-based and non-invasive blood pressure pulse amplitude ratio during a Valsalva maneuver.
次要结局
- Phases of valsalva pulse response(5 minuntes)