Clinical Trial: Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: University Hospital, Limoges

Current Primary Outcome: Onset of a laryngeal edema within 24 hours after a planned tracheal extubation

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • - Severity of laryngeal edema (minor or major)
  • - Time to onset of edema (in minutes) after tracheal extubation
  • - Need for a tracheal re-intubation


Original Secondary Outcome: Same as current

Information By: University Hospital, Limoges

Dates:
Date Received: September 12, 2005
Date Started: December 2000
Date Completion: January 2002
Last Updated: September 12, 2005
Last Verified: September 2005