Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids
September 12, 2005 updated by: University Hospital, Limoges
Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids: a Prospective, Double-Blind, Placebo-Controlled Trial.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment
670
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Angouleme, France
- Réanimation médicale et chirurgicale - Hôpital d'Angoulême
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Brive, France
- Service de Réanimation - CH de Brive
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Chartres, France
- Service de Réanimation - CH de Chartres
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Chateauroux, France
- Service de Réanimation - CH de Chateauroux
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Cholet, France
- Réanimation polyvalente - Hôpital de Cholet
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Dreux, France
- Service de Réanimation - CH de Dreux
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Le Mans, France
- Service de Réanimation - CH de Le Mans
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Limoges, France, 87042
- Service de Réanimation Polyvalente - Hôpital Dupuytren
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Orleans, France
- Réanimation polyvalente - Hôpital d'Orléans
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Poitiers, France
- Service Réanimation - CH de Poitiers
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Saint-Malo, France
- Service de Réanimation - CH Saint Malo
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Saint-Nazaire, France
- Service de Réanimation - CH de Saint Nazaire
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Saintes, France
- Service de Réanimation - CH de Saintes
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Tours, France
- Réanimation Médicale - Hôpital Bretonneau
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Vannes, France
- Service de Réanimation - CH de Vannes
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Onset of a laryngeal edema within 24 hours after a planned tracheal extubation
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Secondary Outcome Measures
Outcome Measure |
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- Severity of laryngeal edema (minor or major)
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- Time to onset of edema (in minutes) after tracheal extubation
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- Need for a tracheal re-intubation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bruno Francois, MD, CH Limoges
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1097/00003246-198305000-00009.
- 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. doi: 10.1097/00000542-199208000-00004.
- 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. doi: 10.1007/BF02044118.
- 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. doi: 10.1016/S0140-6736(07)60526-1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2000
Study Completion
January 1, 2002
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
September 20, 2005
Last Update Submitted That Met QC Criteria
September 12, 2005
Last Verified
September 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Otorhinolaryngologic Diseases
- Laryngeal Diseases
- Edema
- Laryngeal Edema
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
Other Study ID Numbers
- AFSSAPS 001533
- CIC0203/023
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.