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Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids
This study has been completed.
Study NCT00199576   Information provided by University Hospital, Limoges
First Received: September 12, 2005   No Changes Posted

September 12, 2005
September 12, 2005
December 2000
 
Onset of a laryngeal edema within 24 hours after a planned tracheal extubation
Same as current
No Changes Posted
  • - Severity of laryngeal edema (minor or major)
  • - Time to onset of edema (in minutes) after tracheal extubation
  • - Need for a tracheal re-intubation
Same as current
 
Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids
Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids: a Prospective, Double-Blind, Placebo-Controlled Trial.

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.

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.

Phase III
Interventional
Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Post-Extubation Laryngeal Edema
Drug: Methylprednisolone
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
670
January 2002
 

Inclusion Criteria:

  • Adult ≥ 18 years
  • Intubated for ≥ 36 hours
  • Scheduled extubation
  • Informed written consent

Exclusion Criteria:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00199576
 
AFSSAPS 001533, CIC0203/023
University Hospital, Limoges
 
Study Chair: Eric Bellissant, MD, PhD CHU Rennes
Principal Investigator: Bruno Francois, MD CH Limoges
University Hospital, Limoges
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP