Clinical trial NCT00199576: Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids
Official title: Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids: a Prospective, Double-Blind, Placebo-Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-Extubation Laryngeal Edema
Keywords: Corticosteroids
Laryngotracheal injury
Intubation-extubation
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 670
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Onset of a laryngeal edema within 24 hours after a planned tracheal extubation
Secondary outcomes:
measure: - Severity of laryngeal edema (minor or major)
measure: - Time to onset of edema (in minutes) after tracheal extubation
measure: - Need for a tracheal re-intubation
Other outcomes:
Locations:
city: Angouleme
country: France
facility: Réanimation médicale et chirurgicale - Hôpital d'Angoulême
city: Brive
country: France
facility: Service de Réanimation - CH de Brive
city: Chartres
country: France
facility: Service de Réanimation - CH de Chartres
city: Chateauroux
country: France
facility: Service de Réanimation - CH de Chateauroux
city: Cholet
country: France
facility: Réanimation polyvalente - Hôpital de Cholet
city: Dreux
country: France
facility: Service de Réanimation - CH de Dreux
city: Le Mans
country: France
facility: Service de Réanimation - CH de Le Mans
city: Limoges
country: France
facility: Service de Réanimation Polyvalente - Hôpital Dupuytren
city: Orleans
country: France
facility: Réanimation polyvalente - Hôpital d'Orléans
city: Poitiers
country: France
facility: Service Réanimation - CH de Poitiers
city: Saint-Malo
country: France
facility: Service de Réanimation - CH Saint Malo
city: Saint-Nazaire
country: France
facility: Service de Réanimation - CH de Saint Nazaire
city: Saintes
country: France
facility: Service de Réanimation - CH de Saintes
city: Tours
country: France
facility: Réanimation Médicale - Hôpital Bretonneau
city: Vannes
country: France
facility: Service de Réanimation - CH de Vannes
Study officials:
affiliation: CHU Rennes
name: Eric Bellissant, MD, PhD
role: STUDY_CHAIR
affiliation: CH Limoges
name: Bruno Francois, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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. doi: 10.1007/BF02044118.
citation: 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.