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Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids

U

University of Limoges (UL)

Status and phase

Completed
Phase 3

Conditions

Post-Extubation Laryngeal Edema

Treatments

Drug: Methylprednisolone

Study type

Interventional

Funder types

Other

Identifiers

NCT00199576
CIC0203/023
AFSSAPS 001533

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

15

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Data sourced from clinicaltrials.gov

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