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临床试验/NCT00199576
NCT00199576已完成3 期

Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids: a Prospective, Double-Blind, Placebo-Controlled Trial.

University Hospital, Limoges21 个研究点 分布在 1 个国家目标入组 670 人开始时间: 2000年12月1日最近更新:
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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

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

研究者

发起方
University Hospital, Limoges
申办方类型
Other

研究点 (21)

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