Early Tracheotomy Versus Prolonged Endotracheal Intubation in Intensive Care Unit (ICU) Patients
Phase 3
Terminated
- Conditions
- Respiratory Insufficiency
- Registration Number
- NCT00127621
- Lead Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Brief Summary
This is a phase III trial comparing early tracheotomy versus prolonged endotracheal intubation in intensive care unit patients needing prolonged ventilatory support.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 468
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method number of ventilatory free days between days 1 and 28 cumulated incidence of nosocomial pneumonia between days 1 and 28 28 days mortality
- Secondary Outcome Measures
Name Time Method number of septic episodes accidental extubation time on mechanical ventilation time in the ICU amount of sedation 60 days mortality
Trial Locations
- Locations (1)
Institut Gustave Roussy
🇫🇷Villejuif, France
Institut Gustave Roussy🇫🇷Villejuif, France