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| ID | Type | Description | Link |
|---|---|---|---|
| CIC0203/023 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Onset of a laryngeal edema within 24 hours after a planned tracheal extubation |
| Measure | Description | Time Frame |
|---|---|---|
| - Severity of laryngeal edema (minor or major) | ||
| - Time to onset of edema (in minutes) after tracheal extubation | ||
| - Need for a tracheal re-intubation |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Bellissant, MD, PhD | Rennes University Hospital | Study Chair |
| Bruno Francois, MD | CH Limoges | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Réanimation médicale et chirurgicale - Hôpital d'Angoulême | Angoulême | France | ||||
| Service de Réanimation - CH de Brive |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6839788 | Background | 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. | |
| 1642342 | Background | 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. |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| 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 |
| 8905428 | Background | 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. |
| 17398307 | Derived | 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. |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |