The Effectiveness of Oral Care With Chlorhexidine in Medical Intensive Care Unit:Ventilator-associated Pneumonia and Patient Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 2
- 主要终点
- Incidence of ventilator-associated event within ICU admission
研究概览
简要总结
Oral care with chlorhexidine was used to be considered an effective way to prevent ventilator-associated pneumonia (VAP). However, recent evidence revealed that oral care with chlorhexidine may associate with higher mortality and increasing risks of acute respiratory distress syndrome due to the aspiration of chlorhexidine. In addition, the majority of relevant studies in the past have only focused on cardiothoracic intensive care unit (ICU) or post-operation patients. Thus, whether this is effective and safe for medical ICU patients remains unclear.
详细描述
Ventilator-associated pneumonia (VAP) is one of the most common hospital-acquired infections in the ICU, associated with an increased hospital stay, increased cost of treatment, prolonged ventilator days, and increased morbidity and mortality rates (Divatia et al, 2019). The overall incidence of VAP was around 12% in Asia and nearly 8% in Taiwan in the past 30 years (Bonell et al, 2019), with a mortality rate that may exceed 45% for those receiving mechanical ventilation (Feng et al, 2019). Therefore, the prevention of VAP is a key part of managing patients undergoing mechanical ventilation.
Oral decolonization by mouthwash using a chlorhexidine-contained solution was suggested by accumulated evidence in preventing VAP (Dai et al, 2022). However, controversial opinions existed from a few different points of view. First of all, Klompas et al (2014) conducted a meta-analysis that showed the effectiveness of chlorhexidine (CHG) oral care in preventing VAP was limited only to cardiac surgery patients (Klomopas et al, 2014). Second, recent evidence showed a possibility of unfavored outcomes related to the use of CHG mouthwash by increased mortality either in the ICU (Price et al, 2014) or the general ward (Deschepper et al, 2018). Last but not least, the subjectiveness of the diagnostic criteria of VAP had led to the discussion on the credibility of the outcome in relevant studies (Skrupky et al, 2016). Therefore, the US Centers for Disease Control and the National Healthcare Safety Network have proposed alternative diagnostic criteria for the ventilator-associated event (VAE) as alternation (Peña-López et al, 2022).
The objective of this study was to examine the effectiveness of oral care with 0.12% CHG in MICU patients for the prevention of ventilator-associated events.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged over 20 years old
- •admitted to MICU
- •an oral endotracheal tube inserted under mechanically ventilated
排除标准
- •an endotracheal tube inserted over 24 hours before enrollment
- •intubated because of trauma, burn, operation, or neurological disease
- •already suffered from oral ulcers before intubation
- •known history of allergic reaction to CHG
- •use of ECMO
结局指标
主要结局
Incidence of ventilator-associated event within ICU admission
时间窗: Will be surveyed retrospectively through study completion within 3 months
The US CDC has proposed an objective diagnostic criteria to identify adverse events during mechanical ventilation, which comprises three levels: ventilator-associated condition (VAC), infection-related ventilator-associated condition (IVAC), and possible ventilator-associated pneumonia (PVAP).
次要结局
- Hospital mortality(Will be surveyed retrospectively through study completion within 3 months)
- ICU length of stay(Will be surveyed retrospectively through study completion within 3 months)
- Hospital length of stay(Will be surveyed retrospectively through study completion within 3 months)
- ICU mortality(Will be surveyed retrospectively through study completion within 3 months)
- Changes in the oral health status evaluated by the Beck Oral Assessment Scale(The surveys will be conducted within 24 hours of patient enrollment, within the fourth day after the patient is intubated, and within the 1 day following extubation.)
- Changes in the oral health status evaluated by the Mucosal-Plaque Score(The surveys will be conducted within 24 hours of patient enrollment, within the fourth day after the patient is intubated, and within the 1 day following extubation.)
- Incidence of Ventilator-Associated Pneumonia(From the date of intubation until the first occurrence of extubation or in-ICU death, whichever occurs first, assessed up to 28 days.)