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Clinical Trials/NCT00127621
NCT00127621
Terminated
Phase 3

Early Tracheotomy Versus Prolonged Endotracheal Intubation in Intensive Care Unit Patients

Gustave Roussy, Cancer Campus, Grand Paris1 site in 1 country468 target enrollmentApril 2002
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ConditionsRespiratory Insufficiency

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Respiratory Insufficiency
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Enrollment
468
Locations
1
Primary Endpoint
cumulated incidence of nosocomial pneumonia between days 1 and 28
Status
Terminated
Last Updated
20 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
April 2002
End Date
April 2005
Last Updated
20 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

cumulated incidence of nosocomial pneumonia between days 1 and 28

number of ventilatory free days between days 1 and 28

28 days mortality

Secondary Outcomes

  • number of septic episodes
  • accidental extubation
  • amount of sedation
  • time in the ICU
  • 60 days mortality
  • time on mechanical ventilation

Study Sites (1)

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