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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00127621
First Posted: August 8, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
  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
Intervention Model: Parallel Assignment
Masking: None (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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00127621


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

ClinicalTrials.gov Identifier: NCT00127621     History of Changes
Other Study ID Numbers: TRACHEO
First Submitted: August 5, 2005
First Posted: August 8, 2005
Last Update Posted: December 9, 2005
Last Verified: August 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