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
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
- 否
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
Craig M. Dale
Principal Investigator
University of Toronto
