Post-Extubation Laryngeal Edema Clinical Trial
Official title:
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.
| Status | Completed |
| Enrollment | 670 |
| Est. completion date | January 2002 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| 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 | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Limoges |
France,
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. — View Citation
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. — View Citation
Kastanos N, Estopá Miró R, Marín Perez A, Xaubet Mir A, Agustí-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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Onset of a laryngeal edema within 24 hours after a planned tracheal extubation | |||
| Secondary | - Severity of laryngeal edema (minor or major) | |||
| Secondary | - Time to onset of edema (in minutes) after tracheal extubation | |||
| Secondary | - Need for a tracheal re-intubation |