跳至主要内容
临床试验/NCT06175091
NCT06175091
招募中
不适用

Impact of an Alarm Management Protocol on Noise Pollution and Patient Safety in Intensive Care Units

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 514 人2024年2月8日

概览

阶段
不适用
干预措施
alarm management left to the discretion of the nurse
疾病 / 适应症
Intensive Care Unit
发起方
Centre Hospitalier Universitaire de Saint Etienne
入组人数
514
试验地点
1
主要终点
efficiency criterion: the number of alarms per patient per day
状态
招募中
最后更新
上个月

概览

简要总结

Resuscitation patients are monitored for various physiological parameters. When these parameters exceed abnormal thresholds, an audible alarm is triggered. Given the complexity of physiological situations and the number of monitored parameters, the number of alarms within an intensive care unit is significant. In the literature, the number ranges from 100 to 350 alarms per patient per day. Among these alarms, 74 to 99% are deemed irrelevant as they provide false or insignificant information. This study will enable to assess the efficacy of a restrictive protocol for managing alarms as a means of rationalizing their use.

详细描述

The large volume of unnecessary alarms has multiple negative repercussions. Firstly, the excessively loud sound environment present in most resuscitation services causes stress and discomfort for both patients and caregivers. Additionally, nurses become desensitised and less responsive when the number of alarms is high, particularly if many of them are ultimately pointless. Finally, multiple interruptions of tasks associated with alarms that require responses are sources of errors in the execution of care and medication preparation. These interruptions contribute to a phenomenon known as "alarm fatigue", which many authorsand health authorities consider a threat to patient safety.The intensive care unit of the Saint-Etienne University Hospital has had a long-standing interest in this topic, and has a computerized data collection tool that permits exhaustive analysis of all alarm signals originating from each resuscitation bed. This study will enable to assess the efficacy of a restrictive protocol for managing alarms as a means of rationalizing their use.

注册库
clinicaltrials.gov
开始日期
2024年2月8日
结束日期
2028年2月28日
最后更新
上个月
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

入排标准

入选标准

  • Patient aged ≥ 18 years
  • Patient admitted to the intensive care unit of the ST-ETIENNE University Hospital
  • Patient affiliated or entitled to a social security system
  • Patient having received informed information about the study and having co-signed, with the investigator, a consent to participate in the study or, for patients who are unable to consent due to health condition, a trusted person/family member who has been informed about the study and has who has co-signed, with the investigator, a consent to participate

排除标准

  • Pregnant and nursing women
  • Persons of legal age under guardianship

研究组 & 干预措施

control group

Usual management, i.e. alarm management left to the discretion of the nurse caring for the patient.

干预措施: alarm management left to the discretion of the nurse

intervention group

restrictive alarm strategy

干预措施: restrictive alarm use strategy

结局指标

主要结局

efficiency criterion: the number of alarms per patient per day

时间窗: 1 month

An efficiency criterion: the number of alarms per patient per day

A safety criterion: the length of time patients have potentially dangerous heart rate, blood pressure or oxygen saturation values

时间窗: 1 month

A safety criterion: the length of time patients have potentially dangerous heart rate, blood pressure or oxygen saturation values.

次要结局

  • Incidence of serious adverse events(1 month)
  • Evaluation of patient perception using the Discomforts of intensive care patients questionnaire(1 month)
  • Alarm response time(1 month)
  • Sound level measurement using a sound level meter(7 days)

研究点 (1)

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