Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids

Sponsor

University Hospital, Limoges (Other)

Overall Status

Completed

CT.gov ID

NCT00199576

Collaborator

(none)

670

Enrollment

Locations

Duration (Months)

44.7

Patients Per Site

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-Extubation Laryngeal Edema	Drug: Methylprednisolone	Phase 3

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Dec 1, 2000

Study Completion Date :

Jan 1, 2002

Outcome Measures

Primary Outcome Measures

Onset of a laryngeal edema within 24 hours after a planned tracheal extubation []

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Réanimation médicale et chirurgicale - Hôpital d'Angoulême	Angouleme	France
2	Service de Réanimation - CH de Brive	Brive	France
3	Service de Réanimation - CH de Chartres	Chartres	France
4	Service de Réanimation - CH de Chateauroux	Chateauroux	France
5	Réanimation polyvalente - Hôpital de Cholet	Cholet	France
6	Service de Réanimation - CH de Dreux	Dreux	France
7	Service de Réanimation - CH de Le Mans	Le Mans	France
8	Service de Réanimation Polyvalente - Hôpital Dupuytren	Limoges	France	87042
9	Réanimation polyvalente - Hôpital d'Orléans	Orleans	France
10	Service Réanimation - CH de Poitiers	Poitiers	France
11	Service de Réanimation - CH Saint Malo	Saint-Malo	France
12	Service de Réanimation - CH de Saint Nazaire	Saint-Nazaire	France
13	Service de Réanimation - CH de Saintes	Saintes	France
14	Réanimation Médicale - Hôpital Bretonneau	Tours	France
15	Service de Réanimation - CH de Vannes	Vannes	France