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临床试验/NCT03382730
NCT03382730已完成不适用

A Multi-centered Stepped Wedge Cluster Randomized Controlled Trial of the De-adoption of Oral Chlorhexidine Prophylaxis and Implementation of an Oral Care Bundle for Ventilated Critically Ill Patients

University of Toronto5 个研究点 分布在 1 个国家目标入组 3,260 人开始时间: 2017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
入组人数
3,260
试验地点
5
主要终点
Intensive Care Unit (ICU) Mortality

研究概览

简要总结

The objective of the CHORAL study is to evaluate the de-adoption of oral chlorhexidine and the introduction of a bundle of oral care practices on selected outcomes in critically ill mechanically ventilated adults.

详细描述

Infrequent or ineffective oral care can lead to mouth discomfort and lung infection for patients treated with ventilators (breathing machines) in intensive care units (ICUs). A commonly used mouthwash called chlorhexidine can reduce lung infection but most recent evidence shows it may increase the risk of death. In this study 6 participating intensive care units (ICUs) will de-adopt oral chlorhexidine and introduce a bundle of oral care practices using a multi-faceted educational tool kit. The investigators will measure changes in patient-oriented outcomes including mortality, ventilator-associated complications (VACs) and oral health status. A concurrent process evaluation will study how the intervention is delivered and received by patients and clinicians..

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

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

  • All patients who receive mechanical ventilation in the participating ICUs.

排除标准

  • Does not meet inclusion criteria.

结局指标

主要结局

Intensive Care Unit (ICU) Mortality

时间窗: 14 months

All-cause mortality at time of ICU discharge

次要结局

  • Beck Oral Assessment Score (BOAS), Modified(14 months)
  • Infection-related ventilator-associated complications (IVACs)(14 months)
  • Critical Care Pain Observational Tool (CPOT)(14 months)
  • Oral Dryness - Numeric Rating Intensity Scale (NRS)(14 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Craig M. Dale

Principal Investigator

University of Toronto

研究点 (5)

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