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临床试验/NCT02881645
NCT02881645Unknown不适用

Prevention of Critical Incidents Related to the Nursing With Patients in Intensive Care Units PREVENIR Study.

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 59,400 人开始时间: 2019年5月6日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
59,400
试验地点
1
主要终点
Proportion of critical incidents linked to nursing

研究概览

简要总结

The purpose of this study is to assess the effectiveness of a best practices nursing protocol in intensive care units on the occurrence of critical incidents compared to the common practices.

详细描述

To develop the best practices nursing protocol in intensive care units, three steps were necessary:

  1. An incidence study of occurrence of critical incidents linked to nursing was conducted during a month in nine intensive care units to identify high risk clinical situations
  2. A qualitative study (individual interviews and focus groups) with nurses was led to elicit nurse's risk anticipatory strategies during nursing
  3. Based on the results of the two previous step, a working group proposed a best nursing practices protocol to limit critical incidents

Methodology to assess the effectiveness of the protocol of best nursing practices:

The statistical unit is the nursing act for one patient meeting the inclusion criteria (a patient is nursed two times or more per day) Nine intensive care units are included in the study Intensive care units includes 127 beds, their average occupancy rate is approximately 80 % which means about 330 nursing a day and about 9900 nursing a month.

An occurrence of critical incidents (primary outcome measure) of 25% is expected (approximately 2475 critical incidents per month). To show a reduction of 50% of critical incidents in the interventional group, 6 month inclusion will be necessary, whatever the value of the inflation coefficient.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Patient in intensive care units
  • Patient who has received complete information on the organization of the research and who has not objected to his participation and the exploitation of his data

排除标准

  • Moribund patients
  • Nursing made in the chair or in the shower stretcher
  • Patient able to wash and dress alone (or just with the assistance of a nurse)
  • Person under legal protection
  • Person deprived of liberty by a judicial or administrative decision
  • Person being the object of psychiatric care by virtue of articles L. 3212-1 and L. 3213-1 of the french Code of Public Health

结局指标

主要结局

Proportion of critical incidents linked to nursing

时间窗: 6 month

The need to call a doctor Or the presence of three failures (desaturation, desadaptation, hypotension, hypertension, bradycardia, tachycardia, cardiac rhythm disorder, Pain) Or one failure persisting more than 60 min Or accidental remove of invasive equipment during nursing Or death

次要结局

未报告次要终点

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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