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Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00199576
First Posted: September 20, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Limoges
  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 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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


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:
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
CIC0203/023
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

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
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents