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Early Tracheotomy Versus Prolonged Endotracheal Intubation in Intensive Care Unit Patients


Phase 3
18 Years
N/A
Not Enrolling
Both
Respiratory Insufficiency

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Trial Information

Early Tracheotomy Versus Prolonged Endotracheal Intubation in Intensive Care Unit Patients


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

28 days mortality

Principal Investigator

François BLOT, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

TRACHEO

NCT ID:

NCT00127621

Start Date:

April 2002

Completion Date:

April 2005

Related Keywords:

  • Respiratory Insufficiency
  • ICU patients needing prolonged ventilatory support
  • Respiratory Insufficiency

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