Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids: a Prospective, Double-Blind, Placebo-Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 670
- 试验地点
- 21
- 主要终点
- Onset of a laryngeal edema within 24 hours after a planned tracheal extubation
研究概览
简要总结
Tracheal intubation is a frequent procedure in intensive care units (ICU). Post-extubation laryngeal edema is a frequent complication with potential morbidity and mortality, and may lead to urgent tracheal re-intubation. Corticosteroids have been proposed to reduce the incidence of post-extubation laryngeal edema. A few clinical studies have been conducted in adult ICU patients and have led to discrepant results. These discrepancies may be related to the time lag separating the administration of the corticosteroids and the planned extubation. Accordingly, we tested the hypothesis that pretreatment with corticosteroids initiated 12 hours before a planned extubation may efficiently prevent the occurrence of postextubation laryngeal edema in critically-ill adults who have been mechanically ventilated for more than 36 hours in the ICU.
详细描述
We conducted a prospective, double-blind, placebo-controlled, multicenter trial of 12-hour-pretreatment by methylprednisolone before a planned extubation in adult patients ventilated for more than 36 hours in the ICU. Methylprednisolone (20 mg) or placebo was first administered intravenously 12 hours before extubation and continued every 4 hours until tube removal. Primary endpoint was the occurrence of laryngeal edema within 24 hours of extubation. Laryngeal edema was clinically diagnosed and considered as major when requiring tracheal reintubation.
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
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 ≥ 18 years
- •Intubated for ≥ 36 hours
- •Scheduled extubation
- •Informed written consent
排除标准
- •pregnancy
- •history of postextubation laryngeal dyspnea
- •laryngeal disease
- •tracheotomy
- •patient receiving corticotherapy prior to admission
- •traumatic intubation
- •participation to this study or to another trial
结局指标
主要结局
Onset of a laryngeal edema within 24 hours after a planned tracheal extubation
次要结局
- - Severity of laryngeal edema (minor or major)
- - Time to onset of edema (in minutes) after tracheal extubation
- - Need for a tracheal re-intubation
