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临床试验/NCT03448861
NCT03448861Unknown不适用

CHroniSense National Early Warning Score Study

BlueWind Medical0 个研究点目标入组 250 人开始时间: 2018年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
250
主要终点
respiratory rate

研究概览

简要总结

ChroniSense Medical Ltd. is developing a wearable medical multi-parametric monitoring system, Polso™. Polso™ provides a number of the parameters employed in various Early Warning Scores (EWS), such as the National Early Warning Score (NEWS), utilised widely in UK hospitals.

The EWS is a physiological track and trigger system that is generated from multi- parameter or aggregate of vital signs measurements for early recognition of clinical deterioration in acutely admitted patients. Patients who are admitted into hospital are monitored with routinely measurements of these parameters that are manually recorded on a clinical chart.

详细描述

ChroniSense Medical Ltd. is developing a wearable medical multi-parametric monitoring system, Polso™. Polso™ provides a number of the parameters employed in various Early Warning Scores (EWS), such as the National Early Warning Score (NEWS), utilised widely in UK hospitals.

The EWS is a physiological track and trigger system that is generated from multi- parameter or aggregate of vital signs measurements for early recognition of clinical deterioration in acutely admitted patients. Patients who are admitted into hospital are monitored with routinely measurements of these parameters that are manually recorded on a clinical chart.

The parameters of the NEWS include: 1) respiratory rate pulse rate, 2) oxygen saturations, 3) body temperature; 4) systolic blood pressure, 5) heart rate, and 6) level of consciousness. Polso™ acquires, derives, and processes a number of physiological parameters. While ECG is not currently employed in NEWS, other parameters which are used in NEWS are available in the Polso™ system. In cases where manual testing is preferred for any parameter, such as use of supplemental oxygen, the individual score can be entered into the system manually. Polso™, as a wrist-based device, could enable a degree of flexibility in patient care and management.

The goal of this study is to evaluate the suitability of Polso™ as a data acquisition and processing platform capable of providing EWS summaries, against the currently employed NEWS system at the Milton Keynes University Hospital (MKUH) Cardiology Unit. The Polso™ will be employed strictly as a data-gathering system, and will not be used to influence any clinical decisions; the standard NEWS as currently employed will fulfill all its normal clinical roles.

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 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participant is willing and able to give informed consent for participation in the study
  • Male or female, aged 18 years or above

排除标准

  • Unable or unwilling to give valid consent for participation in the study
  • Known history of allergy to nylon
  • Current diagnosis of sustained or non-sustained ventricular/atrial arrhythmia (Ventricular tachycardia, supraventricular tachycardia, atrial fibrillation, bigeminy and trigeminy)
  • Weak pulse
  • Patients with infectious diseases requiring isolation such as Methicillin Resistant Staphylococcus Aureus (MRSA), Clostridium difficile and Extended Spectrum Beta-Lactamases (ESBL)
  • Patients with implantable defibrillators, pacemakers or neurostimulators
  • Patients with Parkinson disease or essential tremor
  • Patients with poor Llead I ECG signal

研究组 & 干预措施

Polso Wearable watch

Experimental

Polso Wearable watch for the purpose of NEWS measurement

干预措施: Polso Wearebale watch (Device)

结局指标

主要结局

respiratory rate

时间窗: Through study completion, an average of 1 year

number of breaths per minute obtained by the Polso™

pulse rate

时间窗: Through study completion, an average of 1 year

bpm obtained by the Polso™

oxygen saturation

时间窗: Through study completion, an average of 1 year

percent obtained by the Polso™

blood pressure

时间窗: Through study completion, an average of 1 year

millimeters of mercury obtained by the Polso™

body temperature

时间窗: Through study completion, an average of 1 year

Celsius temperature scale obtained by the Polso™

次要结局

未报告次要终点

研究者

发起方
BlueWind Medical
申办方类型
Industry
责任方
Sponsor

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