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Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids

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ClinicalTrials.gov Identifier: NCT00199576
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : September 20, 2005
Information provided by:

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  (Clinical Trial)
Estimated Enrollment : 670 participants
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 : December 2000
Estimated Study Completion Date : January 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema Steroids
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Onset of a laryngeal edema within 24 hours after a planned tracheal extubation

Secondary Outcome Measures :
  1. - Severity of laryngeal edema (minor or major)
  2. - Time to onset of edema (in minutes) after tracheal extubation
  3. - Need for a tracheal re-intubation

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199576

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00199576     History of Changes
Other Study ID Numbers: AFSSAPS 001533
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: September 20, 2005
Last Verified: September 2005

Keywords provided by University Hospital, Limoges:
Laryngotracheal injury

Additional relevant MeSH terms:
Laryngeal Edema
Signs and Symptoms
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents