跳至主要内容
临床试验/NCT07335575
NCT07335575招募中不适用

Study of Good Clinical Practice Regarding the Use of Physical Restraints in the Emergency Departments of Strasbourg University Hospital

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2025年4月29日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
450
试验地点
1
主要终点
Proportion of cases in accordance with best practice recommendations (in %)

研究概览

简要总结

Physical restraint in healthcare settings is an ethical issue. The question of deprivation of liberty, as posed by this practice, has persisted throughout history. In psychiatric wards, physical restraint is governed by strict regulations, enshrined in the Public Health Code. This legal framework is absent from the investigator's emergency departments, despite their frequent involvement in the use of restraint. Several studies have highlighted risk factors associated with restraint. These studies have also highlighted the risks associated with restraint. A best practice guideline published by the French Society of Emergency Medicine (SFMU) in 2021 has provided guidelines for practices within our emergency departments. The objective of this study is to determine whether this guideline is followed by practitioners in the emergency departments of Strasbourg University Hospital. The investigators will also analyze the difference between cases that comply with the recommendations and those that do not. Analyses will also be conducted on the subjects most at risk of restraint, the experiences of restrained patients, the times of day when physical restraint is most likely to be applied, the reasons for restraint, and the nature of the physical and chemical restraint.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

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 patient (≥18 years)
  • Patient who was restrained during their visit to the University Hospital's emergency department between January 1, 2023, and June 30, 2023.

排除标准

  • Subject (and/or their legal representative, if applicable) must have expressed their objection to the reuse of their data for scientific research purposes.

结局指标

主要结局

Proportion of cases in accordance with best practice recommendations (in %)

时间窗: Up to 6 months

Proportion of cases in accordance with the best practice guidelines of the French Society of Emergency Medicine (SFMU) among all patient cases that underwent physical restraint in the emergency department of the University Hospital over a 6-month period

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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