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临床试验/NCT02427828
NCT02427828已完成不适用

Continuous, Ambulatory, Non Invasive, Vital Sign Monitoring Using VRES of Cardiac Surgical Patients Following Discharge From Intensive Care. Impact on Detection of Physiological Deterioration

OBS Medical Ltd1 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2013年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
208
试验地点
1
主要终点
Incidence of ward cardiac arrests

研究概览

简要总结

Failure to recognise deterioration early is a major cause of preventable deaths amongst hospital patients. The investigators wish to study whether continuous monitoring of 'vital signs' (pulse rate, breathing rate, and blood oxygen saturations) with computer modeled alerting to detect patient deteriorations can reduce cardiac arrest rate and critical care readmissions from the wards by alerting staff to clinical deteriorations more effectively than current paperbased systems.

Continuous monitoring of 'vital signs' can be achieved in two ways. Continuous monitoring of 'vital signs' has traditionally been restricted to the bedside because of the need for the patient to be connected by wires to the monitor.

More recently, advances in telemetry (wireless technology) have allowed the development of wearable devices which allow patients to mobilise freely, whilst constantly monitoring these 'vital signs'.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

入选标准

  • All patients admitted to the Papworth Hospital NHS Foundation Trust for routine cardiovascular surgery and who are discharged from ICU into the study ward (Mallard).

排除标准

  • transplant surgery patients,
  • VAD patients,
  • children (less than 18 years old),
  • prisoners (due to constant observation/security may bias normal level of care),
  • patients who are subject to additional protections: this includes pregnant women, and persons with mental illness and learning disabilities,
  • patients whose anatomy precludes the use of the required monitoring,
  • patients who cannot understand written English (and where no translator is available),
  • patients who are unable to give consent themselves,
  • patients with learning difficulties who cannot understand the information to consent for themselves.

结局指标

主要结局

Incidence of ward cardiac arrests

时间窗: Up to 72hours

Duration of acute hospital stay

次要结局

未报告次要终点

研究者

发起方
OBS Medical Ltd
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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