跳至主要内容
临床试验/NCT03883516
NCT03883516已完成不适用

Improving Emergency Management of Status Epilepticus - a High-fidelity Simulator-based Randomized Controlled Trial

University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2020年12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
124
试验地点
2
主要终点
Time to SE recognition (minutes)

研究概览

简要总结

In the trial the effectiveness of pre-briefing physicians with the current guideline on Status epilepticus (SE) treatment or a consolidated "one page" guideline regarding quality enhancement of the physician's clinical performances is investigated.

详细描述

Status epilepticus (SE) is a life-threatening neurological emergency defined as a state of continuous seizure or multiple seizures without full recovery of sensory, motor and/or cognitive function for at least 30 minutes. To achieve high quality management of SE, the American Epilepsy Society published an evidence-based guideline for the treatment of SE, which serves as reference for most national guidelines, but analyses regarding practicability, strict adherence, correct translation into clinical practice, and identification of recommended treatment steps at risk of being modified or missed are lacking. Simulator-based studies offer a platform for the design of standardized clinical scenarios that enable detailed investigations regarding the effect of the implementation and practicability of treatment guidelines.

This randomized controlled intervention study performed at the simulation center of the medical intensive care units (ICUs) at the University Hospital Basel is to investigate the effectiveness of pre-briefing physicians with both the current guideline on Status epilepticus (SE) treatment or a consolidated "one page" guideline regarding quality enhancement of the physicians' clinical performances..

Physicians from different medical specialties and with different duration of clinical experience will be enrolled. Participants will be randomly assigned to one of the following three pre-briefing groups: (1) no pre-briefing prior to the simulation training; (2) pre-briefing with the current SE treatment guidelines; (3) pre-briefing with the consolidated "one page" SE treatment guideline.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Physicians from different medical specialties working at the University Hospital Basel

排除标准

  • 未提供

结局指标

主要结局

Time to SE recognition (minutes)

时间窗: from start of simulation training until recognition of seizure and/or SE (max. 20 minutes)

time to recognition of seizure and/or SE

次要结局

  • administration of anti-seizure medication(within the first 20 minutes after beginning of the simulation training)
  • quantification of Glasgow Coma Score (GCS)(within the first 20 minutes after beginning of the simulation training)
  • dose of anti-seizure medication(within the first 20 minutes after beginning of the simulation training)
  • time to correct airways protection(from start of simulation training until correct airways protection (max. 20 minutes))

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (2)

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