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Completed

NCT Number: NCT00199576

Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids

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.

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Key information

Conditions

Post-Extubation Laryngeal Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Réanimation médicale et chirurgicale - Hôpital d'Angoulême, Angoulême, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methylprednisolone

Drug

Primary outcomes

  1. Onset of a laryngeal edema within 24 hours after a planned tracheal extubation

Secondary outcomes

  1. - Severity of laryngeal edema (minor or major)

  2. - Time to onset of edema (in minutes) after tracheal extubation

  3. - Need for a tracheal re-intubation

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Official study title

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

Important dates

Study start
2000
Study completion
2002
First posted
Sep 20, 2005
Registry last updated
Sep 20, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.