CTRI/2024/10/074587已完成不适用
Comparative Evaluation of Continuous Vital Sign Monitoring in Intensive care unit: Standard ICU Monitor Versus UbiqVue 2A Wireless Patient Monitoring System with Wearable Biosensor
LifeSignals India Pvt Ltd1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月12日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To assess whether the UbiqVue 2A wireless patch system is able to reliably measure vital signs continuously in the clinical setting, and to determine how well it compares to recorded measurements in standard ICU monitor.
研究概览
简要总结
- The UbiqVue 2A Wearable Biosensor will be attached to the patient chest. It is a sensor which needs to be placed on the chest through medical grade adhesive similar to a chest electrode following the manufacturer’s instructions.
- Vital parameters (ECG, Heart Rate, SpO2, Pulse Rate, PPG, Invasive BP) will be continuously monitored using both the standard ICU monitor and the UbiqVue 2A Wireless Patient Monitoring System.
- The values will be taken from the monitor for comparison
- The clinician will not make treatment decisions based on the wireless monitor data; it will only be used for comparison purposes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients (18 years or older) admitted to the ICU.
- •Patients having an invasive arterial monitor (radial or femoral) as per their clinical condition.
- •3.Male and female.
排除标准
- •Participants with active implantable medical devices such as pacemakers or implanted defibrillators.
- •Participants exposed to magnetic resonance (MR) environment.
- •Participants allergic to adhesive, electrode gel or non-woven materials.
- •Women with pregnancy.
结局指标
主要结局
To assess whether the UbiqVue 2A wireless patch system is able to reliably measure vital signs continuously in the clinical setting, and to determine how well it compares to recorded measurements in standard ICU monitor.
时间窗: Continuous data will be recorded from both devices for up to 48 hours
次要结局
- aims to compare the accuracy and reliability of continuous vital sign monitoring using a standard ICU monitor with the UbiqVue 2A Wireless Patient Monitoring System over a 48-hour period.(Continuous data will be recorded from both devices for up to 48 hours)
研究者
Dr Mathangi Krishnakumar
St John’s Medical College Hospital
研究点 (1)
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