Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids

Phase 3

Completed

• Conditions: Post-Extubation Laryngeal Edema

• Registration Number: NCT00199576
• Lead Sponsor: University Hospital, Limoges

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.

Study Timeline

• Study Start: 2000-12
• Study Completion: 2002-01
• Status Verified: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Last Update Submitted: 2005-09-12
• Study First Posted: 2005-09-20
• Last Update Posted: 2005-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 670

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Onset of a laryngeal edema within 24 hours after a planned tracheal extubation

Secondary Outcome Measures

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

Trial Locations

Locations (15)

Service de Réanimation - CH de Brive; 🇫🇷 Brive, France

Service de Réanimation - CH de Chartres; 🇫🇷 Chartres, France

Service de Réanimation - CH de Dreux; 🇫🇷 Dreux, France

Réanimation polyvalente - Hôpital d'Orléans; 🇫🇷 Orleans, France

Service de Réanimation - CH de Vannes; 🇫🇷 Vannes, France

Service de Réanimation - CH Saint Malo; 🇫🇷 Saint-Malo, France

Service de Réanimation - CH de Saint Nazaire; 🇫🇷 Saint-Nazaire, France

Réanimation Médicale - Hôpital Bretonneau; 🇫🇷 Tours, France

Service Réanimation - CH de Poitiers; 🇫🇷 Poitiers, France

Service de Réanimation - CH de Chateauroux; 🇫🇷 Chateauroux, France

Réanimation polyvalente - Hôpital de Cholet; 🇫🇷 Cholet, France

Réanimation médicale et chirurgicale - Hôpital d'Angoulême; 🇫🇷 Angouleme, France

Service de Réanimation - CH de Le Mans; 🇫🇷 Le Mans, France

Service de Réanimation Polyvalente - Hôpital Dupuytren; 🇫🇷 Limoges, France

Service de Réanimation - CH de Saintes; 🇫🇷 Saintes, France