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Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids

NCT ID: NCT00199576

Last Updated: 2005-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

670 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-12-31

Study Completion Date

2002-01-31

Brief Summary

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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

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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.

Conditions

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Post-Extubation Laryngeal Edema

Keywords

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Corticosteroids Laryngotracheal injury Intubation-extubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Methylprednisolone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Principal Investigators

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Eric Bellissant, MD, PhD

Role: STUDY_CHAIR

CHU Rennes

Bruno Francois, MD

Role: PRINCIPAL_INVESTIGATOR

CH Limoges

Locations

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Réanimation médicale et chirurgicale - Hôpital d'Angoulême

Angoulême, , France

Site Status

Service de Réanimation - CH de Brive

Brivé, , France

Site Status

Service de Réanimation - CH de Chartres

Chartres, , France

Site Status

Service de Réanimation - CH de Chateauroux

Châteauroux, , France

Site Status

Réanimation polyvalente - Hôpital de Cholet

Cholet, , France

Site Status

Service de Réanimation - CH de Dreux

Dreux, , France

Site Status

Service de Réanimation - CH de Le Mans

Le Mans, , France

Site Status

Service de Réanimation Polyvalente - Hôpital Dupuytren

Limoges, , France

Site Status

Réanimation polyvalente - Hôpital d'Orléans

Orléans, , France

Site Status

Service Réanimation - CH de Poitiers

Poitiers, , France

Site Status

Service de Réanimation - CH de Saint Nazaire

Saint-Nazaire, , France

Site Status

Service de Réanimation - CH de Saintes

Saintes, , France

Site Status

Service de Réanimation - CH Saint Malo

St-Malo, , France

Site Status

Réanimation Médicale - Hôpital Bretonneau

Tours, , France

Site Status

Service de Réanimation - CH de Vannes

Vannes, , France

Site Status

Countries

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France

References

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Kastanos N, Estopa Miro R, Marin Perez A, Xaubet Mir A, Agusti-Vidal A. Laryngotracheal injury due to endotracheal intubation: incidence, evolution, and predisposing factors. A prospective long-term study. Crit Care Med. 1983 May;11(5):362-7. doi: 10.1097/00003246-198305000-00009.

Reference Type BACKGROUND
PMID: 6839788 (View on PubMed)

Darmon JY, Rauss A, Dreyfuss D, Bleichner G, Elkharrat D, Schlemmer B, Tenaillon A, Brun-Buisson C, Huet Y. Evaluation of risk factors for laryngeal edema after tracheal extubation in adults and its prevention by dexamethasone. A placebo-controlled, double-blind, multicenter study. Anesthesiology. 1992 Aug;77(2):245-51. doi: 10.1097/00000542-199208000-00004.

Reference Type BACKGROUND
PMID: 1642342 (View on PubMed)

Ho LI, Harn HJ, Lien TC, Hu PY, Wang JH. Postextubation laryngeal edema in adults. Risk factor evaluation and prevention by hydrocortisone. Intensive Care Med. 1996 Sep;22(9):933-6. doi: 10.1007/BF02044118.

Reference Type BACKGROUND
PMID: 8905428 (View on PubMed)

Francois B, Bellissant E, Gissot V, Desachy A, Normand S, Boulain T, Brenet O, Preux PM, Vignon P; Association des Reanimateurs du Centre-Ouest (ARCO). 12-h pretreatment with methylprednisolone versus placebo for prevention of postextubation laryngeal oedema: a randomised double-blind trial. Lancet. 2007 Mar 31;369(9567):1083-9. doi: 10.1016/S0140-6736(07)60526-1.

Reference Type DERIVED
PMID: 17398307 (View on PubMed)

Other Identifiers

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CIC0203/023

Identifier Type: -

Identifier Source: secondary_id

AFSSAPS 001533

Identifier Type: -

Identifier Source: org_study_id