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临床试验/NCT02908659
NCT02908659已完成不适用

Relevance and Possible Nuisances of Respiratory Rate Alarm Generated by Multi-parametric Monitors in Non Ventilated ICU Patients.A Prospective, Monocentric, Observational Study

Centre Hospitalier Departemental Vendee1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2016年9月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
122
试验地点
1
主要终点
Number of useful alarms within 2000 patient-monitored hours

研究概览

简要总结

In ICU setting, a large number of medical devices are attached to patients, generating numerous alarm signals. Several studies have demonstrated that most of these alarms are not clinically relevant and tend to lower the attentiveness of healthcare professional and, in turn, lower patient safety.The aim of the study is to assess the relevance of respiratory rate alarm on a monitoring device in non-ventilated ICU patients.

The investigator primary hypothesis is that this alarm is potentially useless. If this hypothesis is confirmed, a second interventional trial will be conducted on the impact of this alarm removal.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Age over 18 years
  • Patient hospitalized in ICU
  • Need for monitoring

排除标准

  • Invasive mechanical ventilation
  • Non-invasive mechanical ventilation
  • Patient not monitored
  • Patient already included in this study
  • Patient hospitalized without consent and/or deprived of liberty by court's decision
  • Patient under guardianship or curators
  • Lack of social insurance
  • Patient's or next of kin's refusal

结局指标

主要结局

Number of useful alarms within 2000 patient-monitored hours

时间窗: through study completion, within 6 months

Number of intervention of healthcare team following a relevant respiratory rate alarm generated by a monitoring device and without any other associated alarm.

次要结局

  • Ratio of artifact alarms among all alarms generated by the monitoring device(through study completion within 6 months)
  • Ratio of technical alarms among all alarms generated by the monitoring device(through study completion within 6 months)
  • Ratio of significant alarms among all alarms generated by the monitoring device(through study completion within 6 months)
  • Number of care activity interrupted by a respiratory rate alarm generated by the monitoring device(through study completion within 6 months)
  • Setting of alarms on the monitoring device(through study completion within 6 months)
  • ICU length of stay(Until discharge from ICU, an expected average of 7 days)
  • all-cause ICU mortality(Until discharge from ICU, an expected average of 7 days ])
  • Ratio of respiratory rate alarms generated by the monitoring device among all ICU alarms(through study completion within 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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