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

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

MedlinePlus related topics:

Edema

ChemIDplus related topics:

Methylprednisolone Corticosteroids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

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
	Service de Réanimation Polyvalente - Hôpital Dupuytren
	Limoges, France, 87042
	Réanimation Médicale - Hôpital Bretonneau
	Tours, France
	Réanimation médicale et chirurgicale - Hôpital d'Angoulême
	Angouleme, France
	Réanimation polyvalente - Hôpital d'Orléans
	Orleans, France
	Réanimation polyvalente - Hôpital de Cholet
	Cholet, France
	Service de Réanimation - CH de Dreux
	Dreux, France
	Service Réanimation - CH de Poitiers
	Poitiers, France
	Service de Réanimation - CH de Saintes
	Saintes, France
	Service de Réanimation - CH de Brive
	Brive, France
	Service de Réanimation - CH de Saint Nazaire
	Saint-Nazaire, France
	Service de Réanimation - CH de Chartres
	Chartres, France
	Service de Réanimation - CH de Chateauroux
	Chateauroux, France
	Service de Réanimation - CH de Vannes
	Vannes, France
	Service de Réanimation - CH de Le Mans
	Le Mans, France
	Service de Réanimation - CH Saint Malo
	Saint-Malo, 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.

Publications indexed to this study:

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.

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

Keywords provided by University Hospital, Limoges:

Corticosteroids

Laryngotracheal injury

Intubation-extubation

Study placed in the following topic categories:

Laryngeal Edema

Signs and Symptoms

Otorhinolaryngologic Diseases

Respiratory Tract Diseases

Methylprednisolone

Prednisolone

Methylprednisolone acetate

Edema

Prednisolone acetate

Laryngeal Diseases

Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Antineoplastic Agents, Hormonal

Antineoplastic Agents

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Gastrointestinal Agents

Antiemetics

Neuroprotective Agents

Protective Agents

Glucocorticoids

Hormones

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on September 05, 2008

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