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Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids

Primary Purpose

Post-Extubation Laryngeal Edema

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Methylprednisolone
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-Extubation Laryngeal Edema focused on measuring Corticosteroids, Laryngotracheal injury, Intubation-extubation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Réanimation médicale et chirurgicale - Hôpital d'Angoulême
  • Service de Réanimation - CH de Brive
  • Service de Réanimation - CH de Chartres
  • Service de Réanimation - CH de Chateauroux
  • Réanimation polyvalente - Hôpital de Cholet
  • Service de Réanimation - CH de Dreux
  • Service de Réanimation - CH de Le Mans
  • Service de Réanimation Polyvalente - Hôpital Dupuytren
  • Réanimation polyvalente - Hôpital d'Orléans
  • Service Réanimation - CH de Poitiers
  • Service de Réanimation - CH Saint Malo
  • Service de Réanimation - CH de Saint Nazaire
  • Service de Réanimation - CH de Saintes
  • Réanimation Médicale - Hôpital Bretonneau
  • Service de Réanimation - CH de Vannes

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2005
Last Updated
September 12, 2005
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT00199576
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Limoges

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Extubation Laryngeal Edema
Keywords
Corticosteroids, Laryngotracheal injury, Intubation-extubation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
670 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Primary Outcome Measure Information:
Title
Onset of a laryngeal edema within 24 hours after a planned tracheal extubation
Secondary Outcome Measure Information:
Title
- Severity of laryngeal edema (minor or major)
Title
- Time to onset of edema (in minutes) after tracheal extubation
Title
- Need for a tracheal re-intubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Bellissant, MD, PhD
Organizational Affiliation
CHU Rennes
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bruno Francois, MD
Organizational Affiliation
CH Limoges
Official's Role
Principal Investigator
Facility Information:
Facility Name
Réanimation médicale et chirurgicale - Hôpital d'Angoulême
City
Angouleme
Country
France
Facility Name
Service de Réanimation - CH de Brive
City
Brive
Country
France
Facility Name
Service de Réanimation - CH de Chartres
City
Chartres
Country
France
Facility Name
Service de Réanimation - CH de Chateauroux
City
Chateauroux
Country
France
Facility Name
Réanimation polyvalente - Hôpital de Cholet
City
Cholet
Country
France
Facility Name
Service de Réanimation - CH de Dreux
City
Dreux
Country
France
Facility Name
Service de Réanimation - CH de Le Mans
City
Le Mans
Country
France
Facility Name
Service de Réanimation Polyvalente - Hôpital Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Réanimation polyvalente - Hôpital d'Orléans
City
Orleans
Country
France
Facility Name
Service Réanimation - CH de Poitiers
City
Poitiers
Country
France
Facility Name
Service de Réanimation - CH Saint Malo
City
Saint-Malo
Country
France
Facility Name
Service de Réanimation - CH de Saint Nazaire
City
Saint-Nazaire
Country
France
Facility Name
Service de Réanimation - CH de Saintes
City
Saintes
Country
France
Facility Name
Réanimation Médicale - Hôpital Bretonneau
City
Tours
Country
France
Facility Name
Service de Réanimation - CH de Vannes
City
Vannes
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
6839788
Citation
Kastanos N, Estopa Miro R, Marin Perez A, Xaubet Mir A, Agusti-Vidal A. Laryngotracheal injury due to endotracheal intubation: incidence, evolution, and predisposing factors. A prospective long-term study. Crit Care Med. 1983 May;11(5):362-7. doi: 10.1097/00003246-198305000-00009.
Results Reference
background
PubMed Identifier
1642342
Citation
Darmon JY, Rauss A, Dreyfuss D, Bleichner G, Elkharrat D, Schlemmer B, Tenaillon A, Brun-Buisson C, Huet Y. Evaluation of risk factors for laryngeal edema after tracheal extubation in adults and its prevention by dexamethasone. A placebo-controlled, double-blind, multicenter study. Anesthesiology. 1992 Aug;77(2):245-51. doi: 10.1097/00000542-199208000-00004.
Results Reference
background
PubMed Identifier
8905428
Citation
Ho LI, Harn HJ, Lien TC, Hu PY, Wang JH. Postextubation laryngeal edema in adults. Risk factor evaluation and prevention by hydrocortisone. Intensive Care Med. 1996 Sep;22(9):933-6. doi: 10.1007/BF02044118.
Results Reference
background
PubMed Identifier
17398307
Citation
Francois B, Bellissant E, Gissot V, Desachy A, Normand S, Boulain T, Brenet O, Preux PM, Vignon P; Association des Reanimateurs du Centre-Ouest (ARCO). 12-h pretreatment with methylprednisolone versus placebo for prevention of postextubation laryngeal oedema: a randomised double-blind trial. Lancet. 2007 Mar 31;369(9567):1083-9. doi: 10.1016/S0140-6736(07)60526-1.
Results Reference
derived

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Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids

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