Validation of the WBPS - Wrist Blood Pressure System A Prospective, Method Comparison, Proof of Concept Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Assessment of the accuracy of a novel algorithm to extract BP estimates from data acquired by the WinPack system, when compared to gold-standard BP devices, with respect to limits of agreement as stated by the IEEE 1708:2014 standard
研究概览
简要总结
The study will evaluate the accuracy of BP measurements by a new algorithm to be embedded to the existing CE-marked WinPack device, compared to two reference devices (one oscillometric and one volume-clamp device), in healthy subjects and patients undergoing a standardized physical-activity hypertensive protocol.
详细描述
Current standard for patient monitoring in acute care such as intensive care units (ICU), operating rooms (OR) or emergency rooms (ER) is the use of expensive, bulky and uncomfortable monitors.
Unfortunately, once discharged from the acute care setting and transferred to a general division for example (low acuity), patients are left with manual measurements of vital signs every 4 to 6 hours, depending on the available resources in nursing. Furthermore, these measurements reflect only the results of the time the measurement is taken (spot check). The combination of manual spot checks and lack of innovative medical technology in 60% of hospital care settings (all non-ICUs and non-OR) represents an important limitation to patient follow-up, with its associated risks and costs.
In particular, when referring to the monitoring of blood pressure (BP), current monitoring practice relies on the use of occlusive pneumatic cuffs inflated around the arm. Based on oscillometric technique, occlusive cuffs not only are uncomfortable, but they provide only intermittent measurements, with the inability to provide a full view of the BP regulation landscape. Therefore, un-detected hypertensive events can be omitted, putting the patient at risk.
The continuous, comfortable and portable measurement of BP in low acuity hospital departments is a major unsolved problem of modern healthcare systems with regards to patient monitoring and safety.
Winmedical (device manufacturer) commercializes a wearable multi-parametric modular medical system, WinPack, to deliver continuous real-time monitoring and recording of vital signs, such as electrocardiography (ECG), respiration rate, BP, blood oxygen saturation, body temperature, and posture, in low-acuity departments to increase the overall clinical performance. A new algorithm to process the raw physiological signals acquired by the WinPack to provide more accurate and more continuous BP measurement is now to be tested.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age >18 years
- •Informed Consent
- •Compliant and able to protocol manoeuvres
排除标准
- •Blood pressure difference between to arms >15mmHg
- •Current or history of tobacco smoking (for the last 5 years, > 5 cigarettes per day),
- •Current alcohol or drug abuse (>4 units per day),
- •Unstable cardiac condition (myocardial infarction < 1 week, pulmonary embolism, ventricular arrhythmia, decompensated heart failure)
- •Severe anaemia (haemoglobin <100g/l)
- •Oxygen therapy
- •Lesion or deficiency on left hand, preventing to perform handgrip exercises
- •Lesion or deficiency on both legs, preventing to perform leg extension exercise
研究组 & 干预措施
WinMedical WinPack device
50 volunteers undergoing experimental protocol according to IEEE 1708:2014 standard
干预措施: WinMedical WinPack device (Device)
结局指标
主要结局
Assessment of the accuracy of a novel algorithm to extract BP estimates from data acquired by the WinPack system, when compared to gold-standard BP devices, with respect to limits of agreement as stated by the IEEE 1708:2014 standard
时间窗: 3 Months
次要结局
未报告次要终点