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Early Tracheotomy Versus Prolonged Endotracheal Intubation in Intensive Care Unit (ICU) Patients

This study has been terminated.
Sponsor:
Information provided by:
Institut Gustave Roussy
ClinicalTrials.gov Identifier:
NCT00127621
First received: August 5, 2005
Last updated: August 24, 2005
Last verified: August 2005
History of Changes
  Purpose

This is a phase III trial comparing early tracheotomy versus prolonged endotracheal intubation in intensive care unit patients needing prolonged ventilatory support.


Condition Intervention Phase
Respiratory Insufficiency
 Procedure: early tracheotomy
Procedure: prolonged endotracheal intubation
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Tracheotomy Versus Prolonged Endotracheal Intubation in Intensive Care Unit Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut Gustave Roussy:

Primary Outcome Measures:
  • 28 days mortality
  • cumulated incidence of nosocomial pneumonia between days 1 and 28
  • number of ventilatory free days between days 1 and 28

Secondary Outcome Measures:
  • time in the ICU
  • time on mechanical ventilation
  • 60 days mortality
  • number of septic episodes
  • accidental extubation
  • amount of sedation

Estimated Enrollment: 468
Study Start Date: April 2002
Estimated Study Completion Date: April 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients under ventilation support for at least 4 days
  • Patients needing ventilatory support for > 7 days
  • Age > 18 years
  • Informed consent signed

Exclusion Criteria:

  • Patients previously tracheotomised
  • Major hemorrhagic risk
  • Patients previously randomised in a trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127621

Locations
France
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Institut Gustave Roussy
Investigators
Principal Investigator: François BLOT, Dr Institut Gustave Roussy
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00127621     History of Changes
Other Study ID Numbers: TRACHEO
Study First Received: August 5, 2005
Last Updated: August 24, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Gustave Roussy:
ICU patients needing prolonged ventilatory support

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013