Atropine for Preventing Ventilator-Associated Pneumonia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Ventilator-Associated Pneumonia
研究概览
简要总结
A double-blind, placebo controlled trial of atropine eye drops used by sublingual way for preventing Ventilator-Associated Pneumonia.
详细描述
A double-blind, placebo controlled trial of atropine eye drops used by sublingual way for preventing Ventilator-Associated Pneumonia was conducted in Passo Fundo - RS, south Brazil. 40 adult patients were included (exploratory stage 2 trial). Interventions were initiated until 48 hours of patients were submitted to orotracheal intubation: 2 drops of atropine (eye drop) by sublingual way, compared to placebo on the same regimen. Efficacy outcomes were pneumonia and death, but safety was also assessed. No difference was observed between the placebo and atropine groups in terms of efficacy and safety outcomes. The small sample and a significance difference in terms of initiating the interventions (medians: 48h for atropine; 24h for placebo) may be a conservative bias. This can not exclude a possible benefit of atropine that should be better evaluated in a stage 3 trial.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Adult patient admitted in intensive care unit with endotracheal intubation and ventilator initiated until 48 hours
排除标准
- •Pneumonia, radiotherapy, chemiotherapy, conditions that interfere with saliva production or change normal oral cavity shape
研究组 & 干预措施
Atropine
干预措施: Atropine (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Ventilator-Associated Pneumonia
时间窗: through the end of the study, an average of one year
Incidence of ventilator-associated pneumonia through the end of the study, an average of one year
次要结局
- Death(through the end of the study, an average of one year)
研究者
Cassiano Mateus Forcelini
Professor, PhD, MD
Universidade de Passo Fundo
