| Home | Search | Study Topics | Glossary |
|
|
|
 |
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||||||
| Brief Title † | 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. | ||||||||
| 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. |
||||||||
| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Onset of a laryngeal edema within 24 hours after a planned tracheal extubation | ||||||||
| Secondary Outcome Measure † | - Severity of laryngeal edema (minor or major) - Time to onset of edema (in minutes) after tracheal extubation - Need for a tracheal re-intubation |
||||||||
| Condition † | Post-Extubation Laryngeal Edema | ||||||||
| Intervention † | Drug: Methylprednisolone | ||||||||
| MEDLINE PMIDs | 6839788, 1642342, 8905428 | ||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Completed | ||||||||
| Enrollment † | 670 | ||||||||
| Start Date † | December 2000 | ||||||||
| Completion Date | January 2002 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | France | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00199576 | ||||||||
| Organization ID | AFSSAPS 001533 | ||||||||
| Secondary IDs †† | CIC0203/023 | ||||||||
| Study Sponsor † | University Hospital, Limoges | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
|
||||||||
| Information Provided By | University Hospital, Limoges | ||||||||
| Verification Date | September 2005 | ||||||||
| First Received Date † | September 12, 2005 | ||||||||
| Last Updated Date | September 12, 2005 | ||||||||
|
