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Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids

Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids: a Prospective, Double-Blind, Placebo-Controlled Trial.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00199576
Enrollment
670
Registered
2005-09-20
Start date
2000-12-31
Completion date
2002-01-31
Last updated
2005-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Extubation Laryngeal Edema

Keywords

Corticosteroids, Laryngotracheal injury, Intubation-extubation

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.

Interventions

DRUGMethylprednisolone

Sponsors

University Hospital, Limoges
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Onset of a laryngeal edema within 24 hours after a planned tracheal extubation

Secondary

MeasureTime frame
- Severity of laryngeal edema (minor or major)
- Time to onset of edema (in minutes) after tracheal extubation
- Need for a tracheal re-intubation

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026