Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids: a Prospective, Double-Blind, Placebo-Controlled Trial.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Post-Extubation Laryngeal Edema
- Sponsor
- University Hospital, Limoges
- Enrollment
- 670
- Locations
- 15
- Primary Endpoint
- Onset of a laryngeal edema within 24 hours after a planned tracheal extubation
- Status
- Completed
- Last Updated
- 20 years ago
Overview
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 Description
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Onset of a laryngeal edema within 24 hours after a planned tracheal extubation
Secondary Outcomes
- - Severity of laryngeal edema (minor or major)
- - Time to onset of edema (in minutes) after tracheal extubation
- - Need for a tracheal re-intubation