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临床试验/NCT01549717
NCT01549717已完成不适用

Feasibility And Efficacy Of Continuous In-Hospital Patient Monitoring

Guy's and St Thomas' NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2012年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
2
主要终点
The number of patients in whom abnormal vital signs are detected by a continuous monitor more than an hour before they are detected according to standard ward practice

研究概览

简要总结

The investigators plan to study patients who have had cardiac surgery. Current standard practice is to monitor patients who have had cardiac surgery using wall-mounted monitors whilst they are on the Overnight Intensive Recovery (OIR) and the cardiac High Dependency Unit (HDU). The wall-mounted monitors monitor the vital signs continuously and alert the nurses if any abnormalities are detected. Once a patient is transferred from HDU to the cardiac surgery ward for the most part they are no longer connected to a continuous monitor. Instead, the majority of patients on the ward have their vital signs only intermittently checked during the day, using a "spot check monitor". There is a small minority, chosen on clinical grounds, who are assessed with wireless "telemetry" monitors for a day or two.

In this study the investigators will continuously monitor the vital signs of all enrolled patients from the time that they leave the operating theatre to the the time they are discharged from hospital. Whilst they are on OIR and HDU they will be monitored with the standard wall-mounted monitors in the normal fashion. When they then move to the ward the investigators will give all enrolled patients a telemetry monitor to wear as well as asking the nurses to check their vital signs with spot check monitors.

The investigators will also collect information about the patients' general state of health and record indicators of worsening in patients' condition so that the investigators can determine how changes in the vital signs relate to deterioration. Finally the investigators plan to survey the patients and nurses to understand their experiences of continuous monitoring and what needs to be changed to improve the patient experience.

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

入选标准

  • Adult (aged over 18 years old)
  • Planned for elective cardiac surgery
  • Post surgery care is planned to be on a study ward

排除标准

  • Inability or refusal to consent
  • Prisoners
  • For palliative care only

研究组 & 干预措施

Elective cardiac surgery patients

Experimental

Patients undergoing elective cardiac surgery

干预措施: Fitting of a wireless telemetry device (Device)

结局指标

主要结局

The number of patients in whom abnormal vital signs are detected by a continuous monitor more than an hour before they are detected according to standard ward practice

次要结局

  • The number of alerts caused by probe off alarms and artefactual readings
  • The specificity of the automated early warning score developed from this data for predicting clinical deterioration
  • The sensitivity of the automated early warning score developed from this data for predicting clinical deterioration
  • The proportion of patient stay for which good quality continuous data is captured

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard Beale

Consultant

Guy's and St Thomas' NHS Foundation Trust

研究点 (2)

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