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

This study has been terminated.
Sponsor:
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00127621
First received: August 5, 2005
Last updated: August 24, 2005
Last verified: August 2005

August 5, 2005
August 24, 2005
April 2002
Not Provided
  • 28 days mortality
  • cumulated incidence of nosocomial pneumonia between days 1 and 28
  • number of ventilatory free days between days 1 and 28
  • - 28 days mortality
  • - cumulated incidence of nosocomial pneumonia between day 1 and 28
  • - number of ventilatory free days between day 1 and 28
Complete list of historical versions of study NCT00127621 on ClinicalTrials.gov Archive Site
  • time in the ICU
  • time on mechanical ventilation
  • 60 days mortality
  • number of septic episodes
  • accidental extubation
  • amount of sedation
  • - time in the ICU
  • - time on mecanical ventilation
  • - 60 days mortality
  • - number of septic episodes
  • - accidental extubation
  • - amount of sedation
Not Provided
Not Provided
 
Early Tracheotomy Versus Prolonged Endotracheal Intubation in Intensive Care Unit (ICU) Patients
Early Tracheotomy Versus Prolonged Endotracheal Intubation in Intensive Care Unit Patients

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Respiratory Insufficiency
  • Procedure: early tracheotomy
  • Procedure: prolonged endotracheal intubation
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
468
April 2005
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00127621
TRACHEO
Not Provided
Not Provided
Gustave Roussy, Cancer Campus, Grand Paris
Not Provided
Principal Investigator: François BLOT, Dr Gustave Roussy, Cancer Campus, Grand Paris
Gustave Roussy, Cancer Campus, Grand Paris
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP