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

Early Tracheotomy Versus Prolonged Endotracheal Intubation in Intensive Care Unit Patients

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00127621

Enrollment

468

Registered

2005-08-08

Start date

2002-04-30

Completion date

2005-04-30

Last updated

2005-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Insufficiency

Keywords

ICU patients needing prolonged ventilatory support

Brief summary

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

Interventions

PROCEDUREearly tracheotomy

PROCEDUREprolonged endotracheal intubation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
28 days mortality	—
cumulated incidence of nosocomial pneumonia between days 1 and 28	—
number of ventilatory free days between days 1 and 28	—

Secondary

Measure	Time frame
number of septic episodes	—
time in the ICU	—
amount of sedation	—
accidental extubation	—
time on mechanical ventilation	—
60 days mortality	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026