Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids
2 other identifiers
interventional
670
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2000
Shorter than P25 for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedSeptember 20, 2005
September 1, 2005
September 12, 2005
September 12, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Onset of a laryngeal edema within 24 hours after a planned tracheal extubation
Secondary Outcomes (3)
- Severity of laryngeal edema (minor or major)
- Time to onset of edema (in minutes) after tracheal extubation
- Need for a tracheal re-intubation
Interventions
Eligibility Criteria
You may qualify if:
- Adult ≥ 18 years
- Intubated for ≥ 36 hours
- Scheduled extubation
- Informed written consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Réanimation médicale et chirurgicale - Hôpital d'Angoulême
Angoulême, France
Service de Réanimation - CH de Brive
Brivé, France
Service de Réanimation - CH de Chartres
Chartres, France
Service de Réanimation - CH de Chateauroux
Châteauroux, 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, 87042, France
Réanimation polyvalente - Hôpital d'Orléans
Orléans, France
Service Réanimation - CH de Poitiers
Poitiers, France
Service de Réanimation - CH de Saint Nazaire
Saint-Nazaire, France
Service de Réanimation - CH de Saintes
Saintes, France
Service de Réanimation - CH Saint Malo
St-Malo, France
Réanimation Médicale - Hôpital Bretonneau
Tours, France
Service de Réanimation - CH de Vannes
Vannes, France
Related Publications (4)
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.
PMID: 6839788BACKGROUNDDarmon 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.
PMID: 1642342BACKGROUNDHo 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.
PMID: 8905428BACKGROUNDFrancois 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.
PMID: 17398307DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Eric Bellissant, MD, PhD
CHU Rennes
- PRINCIPAL INVESTIGATOR
Bruno Francois, MD
CH Limoges
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
December 1, 2000
Study Completion
January 1, 2002
Last Updated
September 20, 2005
Record last verified: 2005-09