Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199576
Status:
COMPLETED
Last Update Posted:
2005-09-20
First Post:
2005-09-12
Brief Title:
Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids
Sponsor:
University Hospital Limoges
Organization:
University Hospital Limoges
Study Overview
Official Title:
Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids a Prospective Double-Blind Placebo-Controlled Trial
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIC0203023 | None | None | None |