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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:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00127621
First received: August 5, 2005
Last updated: August 24, 2005
Last verified: August 2005
  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:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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

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

ClinicalTrials.gov processed this record on November 20, 2014