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NCT00127621 Clinical Trial

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

Respiratory Insufficiency Clinical Trial

Official title:
Early Tracheotomy Versus Prolonged Endotracheal Intubation in Intensive Care Unit Patients

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00127621
Other study ID # TRACHEO
Secondary ID
Status Terminated
Phase Phase 3
First received August 5, 2005
Last updated August 24, 2005
Start date April 2002
Est. completion date April 2005

Study information
Verified date August 2005
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 468
Est. completion date April 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Procedure:
• early tracheotomy

• prolonged endotracheal intubation

Locations
Country Name City State
France Institut Gustave Roussy Villejuif

Sponsors (1)
Lead Sponsor Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 28 days mortality
Primary cumulated incidence of nosocomial pneumonia between days 1 and 28
Primary number of ventilatory free days between days 1 and 28
Secondary time in the ICU
Secondary time on mechanical ventilation
Secondary 60 days mortality
Secondary number of septic episodes
Secondary accidental extubation
Secondary amount of sedation
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