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

This study has been terminated.
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris Identifier:
First received: August 5, 2005
Last updated: August 24, 2005
Last verified: August 2005
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
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Tracheotomy Versus Prolonged Endotracheal Intubation in Intensive Care Unit Patients

Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00127621

Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Principal Investigator: François BLOT, Dr Gustave Roussy, Cancer Campus, Grand Paris
  More Information Identifier: NCT00127621     History of Changes
Other Study ID Numbers: TRACHEO
Study First Received: August 5, 2005
Last Updated: August 24, 2005

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
ICU patients needing prolonged ventilatory support

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases processed this record on May 24, 2017