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

Gustave Roussy

Status and phase: Terminated; Phase 3

Conditions: Respiratory Insufficiency

Treatments: Procedure: early tracheotomy; Procedure: prolonged endotracheal intubation

Study type: Interventional

Funder types: Other

Identifiers

NCT00127621

TRACHEO

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)