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

Phase 3TerminatedNCT00127621

Gustave Roussy, Cancer Campus, Grand Paris468 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

468

Conditions

Respiratory Insufficiency

Interventions

early tracheotomyPROCEDURE

prolonged endotracheal intubationPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Institut Gustave Roussy

Villejuif, France

Outcomes

Primary Outcomes

28 days mortality

cumulated incidence of nosocomial pneumonia between days 1 and 28

number of ventilatory free days between days 1 and 28

Secondary Outcomes

time in the ICU

time on mechanical ventilation

60 days mortality

number of septic episodes

accidental extubation

amount of sedation

Data from ClinicalTrials.gov

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