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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

468 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2005-04-30

Brief Summary

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

Detailed Description

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Conditions

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Respiratory Insufficiency

Keywords

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ICU patients needing prolonged ventilatory support

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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early tracheotomy

Intervention Type PROCEDURE

prolonged endotracheal intubation

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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François BLOT, Dr

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

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Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

Other Identifiers

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TRACHEO

Identifier Type: -

Identifier Source: org_study_id