Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids - Full Text View

Sponsor:	University Hospital, Limoges
Information provided by:	University Hospital, Limoges
ClinicalTrials.gov Identifier:	NCT00199576

Purpose

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	Intervention	Phase
Post-Extubation Laryngeal Edema	Drug: Methylprednisolone	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
Official Title:	Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids: a Prospective, Double-Blind, Placebo-Controlled Trial.

Resource links provided by NLM:

MedlinePlus related topics: Edema

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Medrol veriderm Methylprednisolone Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone Corticosteroids

U.S. FDA Resources

Further study details as provided by University Hospital, Limoges:

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

Estimated Enrollment:	670
Study Start Date:	December 2000
Estimated Study Completion Date:	January 2002

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199576

Locations

France
Réanimation médicale et chirurgicale - Hôpital d'Angoulême
Angouleme, France
Service de Réanimation - CH de Brive
Brive, France
Service de Réanimation - CH de Chartres
Chartres, France
Service de Réanimation - CH de Chateauroux
Chateauroux, 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, 87042
Réanimation polyvalente - Hôpital d'Orléans
Orleans, France
Service Réanimation - CH de Poitiers
Poitiers, France
Service de Réanimation - CH Saint Malo
Saint-Malo, France
Service de Réanimation - CH de Saint Nazaire
Saint-Nazaire, France
Service de Réanimation - CH de Saintes
Saintes, France
Réanimation Médicale - Hôpital Bretonneau
Tours, France
Service de Réanimation - CH de Vannes
Vannes, France

Sponsors and Collaborators

University Hospital, Limoges

Investigators

Study Chair:	Eric Bellissant, MD, PhD	CHU Rennes
Principal Investigator:	Bruno Francois, MD	CH Limoges

More Information

Publications:

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.

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.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00199576 History of Changes
Other Study ID Numbers:	AFSSAPS 001533, CIC0203/023
Study First Received:	September 12, 2005
Last Updated:	September 12, 2005
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Limoges:

Corticosteroids
Laryngotracheal injury
Intubation-extubation

Additional relevant MeSH terms:

Edema
Laryngeal Edema
Signs and Symptoms
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses

Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012