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Sponsored by: |
University Hospital, Limoges |
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Information provided by: | University Hospital, Limoges |
ClinicalTrials.gov Identifier: | NCT00199576 |
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: | 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. |
Estimated Enrollment: | 670 |
Study Start Date: | December 2000 |
Estimated Study Completion Date: | January 2002 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Chair: | Eric Bellissant, MD, PhD | CHU Rennes |
Principal Investigator: | Bruno Francois, MD | CH Limoges |
Study ID Numbers: | AFSSAPS 001533, CIC0203/023 |
Study First Received: | September 12, 2005 |
Last Updated: | September 12, 2005 |
ClinicalTrials.gov Identifier: | NCT00199576 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Corticosteroids Laryngotracheal injury Intubation-extubation |
Laryngeal Edema Signs and Symptoms Otorhinolaryngologic Diseases Respiratory Tract Diseases Methylprednisolone Prednisolone |
Methylprednisolone acetate Edema Prednisolone acetate Laryngeal Diseases Methylprednisolone Hemisuccinate |
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 |