PROSPECTIVE STUDY EVALUATING THE VITAL LABS DIGITAL BLOOD PRESSURE MONITOR (VLDBPM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 343
- 试验地点
- 3
- 主要终点
- Mean difference between BP measures
研究概览
简要总结
The primary endpoints for this study are mean and standard deviation error measurements for the VLDBPM versus manual auscultation.
详细描述
This is a prospective, controlled, single-arm clinical evaluation. Five hundred thirty-two (532) subjects are planned to be evaluated. Each subject's blood pressure will be measured using the VLDBPM and manual auscultation. Each subject will be observed while undergoing a series of blood pressure perturbation challenges. Means measurement differences from the test sensor and the reference auscultation measurements will be used to validate the accuracy of the VDBPM software system.
Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.
Total duration of subject participation will be 1 to 1.5 hours. Total duration of the study is expected to be 6 months.
Following medical history and patient eligibility assessments, eligible patients will be offered participation in the study. Once subjects are consented/enrolled, measurements will be performed in accordance with Data Collection Procedure section below.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female ≥18 and ≤ 85 years of age at the Baseline Visit.
- •Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
- •A minimum of 30% of the data will be derived from male subjects; and a minimum of 30% of the data will be derived from female subjects.
- •A minimum of 50 participants will have dark skin types, as defined by the Fitzpatrick Skin Type classification V or VI.
- •Also, at least 10 participants should exhibit finger calluses, found typically on individuals who play stringed instruments frequently.
排除标准
- •Pregnant and/or breastfeeding.
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- •Are unable or unwilling to undergo all assessments associated with the study.
- •Have a history of poor quality or difficulty performing auscultation measurements.
- •Subjects shall be excluded if the Korotkoff sound [fifth phase (K5)] is not audible
- •Subjects with vascular implants in the arm of measurement, such as those used for dialysis
- •Subject suffering from a medical condition prohibiting blood flow occlusion in either arms.
- •Pre-existing conditions that may interfere with the accuracy or interpretation of auscultatory readings, such as aortic coarctation, arterial-venous malformation, occlusive arterial disease, or the presence of an antecubital bruit.
- •Subjects who have known allergies to nitroglycerin (for subjects undergoing the nitroglycerin challenge).
- •Subjects who have taken short acting nitroglycerin within 4 hours of the scheduled study. Such studies will be deferred for at least 4 hours.
- •Subjects who have taken long acting nitroglycerin within 8 hours of the scheduled study. Such studies will be deferred for at least 8 hours.
- •Subjects with pericardial tamponade, restrictive cardiomyopathy, or constrictive pericarditis, or cardiac output is dependent upon venous return
研究组 & 干预措施
The Vital Labs Digital Blood Pressure Monitor
The Vital Labs Digital Blood Pressure monitor is a software-as-a-medical device (SaMD) that is capable of determining blood pressure, after calibration, using waveform changes observed in photoplethysmogram signals. The VLDBPM captures PPG signals using the existing camera systems on iPhones. These PPG signals are normalized and processed to determine markers of blood pressure change. These markers, when transformed using a predetermined model, are capable of determining blood pressure changes from a known (calibration) set-point.
干预措施: The Vital Labs Digital Blood Pressure Monitor (Device)
结局指标
主要结局
Mean difference between BP measures
时间窗: 1.5 hours
Primary efficacy
Standard deviation of differences between BP measures
时间窗: 1.5 hours
Primary Efficacy
Mean difference between BP measures
时间窗: Baseline
Primary efficacy
Standard deviation of differences between BP measures
时间窗: Baseline
Primary Efficacy
次要结局
未报告次要终点