A Multi-center, Prospective, Pilot Study Intended for Data Collection to Evaluate and Calibrate a Novel Non-invasive Wearable Device for Monitoring Vital Signs
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Level of accordance between the BiPS monitor and the arterial line
研究概览
简要总结
The purpose of this clinical study is to compare the measurement of vital signs (blood pressure, heart rate, respiration rate, blood oxygen levels and body temperature) measured by the non-invasive, continuous and wireless BiPS monitoring device with vital signs measured by current standard of care hospital equipment (blood pressure measurements will be obtained from arterial line) an invasive arterial line. The study will be conducted in two medical centers in Israel and include 50 adult patients that are connected to an arterial line as part of their routine care.
详细描述
BiPS Medical has developed a wearable, wireless device that conveniently monitors important vital sign trends over time - blood pressure (diastolic & systolic), heart and respiration rates, blood oxygen level (SPO2) and body temperature - to aid in identifying clinical deterioration. The device is base on a combination of inflatable mini finger cuff and photoplethysmograph technology.
The aim of this study is to collect data for evaluating and calibrating of the BiPS monitor for monitoring patient vital signs and compare it to current standard of care hospital monitors. The study population includes a total of 50 adult patients that are connected to an arterial line as part of their routine care. The BiPS non-invasive monitor will be attached to participating patients during their stay in the ICU/ recovery in cardiac ICU/Post Anesthesia Care Unit /other hospital designated unit. The device will be placed on the patient for 60 minutes while in hospital bed, in which up to 20 blood pressure measurements are performed (each takes up to 60 seconds). Heart and respiration rates, body temperature and SPO2 will be measured continuously while the device is attached to the patient hand.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Patients aged 18 years and older who agree to sign an informed consent.
- •Patients connected to an arterial line as part of their routine care (e.g., patients recovering from cardiac or other major surgery)
排除标准
- •Pregnant women.
- •Patients under the age of
- •Patients who are not connected to an arterial line as part of their routine care.
- •Unable to give informed consent.
- •Patients with poor or no finger pulse.
结局指标
主要结局
Level of accordance between the BiPS monitor and the arterial line
时间窗: 60 minutes
Correlation between the vital sgns measured on The BiPS non-invasive monitor and those measured through the arterial line
次要结局
未报告次要终点