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临床试验/NCT02704923
NCT02704923已完成2 期

Atropine for Preventing Ventilator-Associated Pneumonia

Universidade de Passo Fundo0 个研究点目标入组 40 人开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

干预措施: Atropine (Drug)

Placebo

Placebo Comparator

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

发起方
Universidade de Passo Fundo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cassiano Mateus Forcelini

Professor, PhD, MD

Universidade de Passo Fundo

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