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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
670
Réanimation médicale et chirurgicale - Hôpital d'Angoulême
Angoulême, France
Service de Réanimation - CH de Brive
Brivé, France
Service de Réanimation - CH de Chartres
Chartres, France
Service de Réanimation - CH de Chateauroux
Châteauroux, France
Réanimation polyvalente - Hôpital de Cholet
Cholet, France
Service de Réanimation - CH de Dreux
Dreux, France
Service de Réanimation - CH de Le Mans
Le Mans, France
Service de Réanimation Polyvalente - Hôpital Dupuytren
Limoges, France
Réanimation polyvalente - Hôpital d'Orléans
Orléans, France
Service Réanimation - CH de Poitiers
Poitiers, France
...and 5 more locations
Onset of a laryngeal edema within 24 hours after a planned tracheal extubation
- Severity of laryngeal edema (minor or major)
- Time to onset of edema (in minutes) after tracheal extubation
- Need for a tracheal re-intubation
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