NCT00292097

A Prospective, Randomized Trial of Early Versus Late Tracheostomy in Trauma Patients With Severe Brain Injury

A Prospective, Randomized Trial of Early Versus Conventional Conversion From Endotracheal Intubation to Percutaneous Tracheostomy for Ventilatory Support of Trauma Patients With Severe Brain Injury

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Memorial Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of early conversion tracheostomy from endotracheal intubation (ET) to percutaneous, dilatational tracheostomy (PDT) in traumatic brain-injured patients requiring prolonged mechanical ventilation.

Detailed description

This is a prospective, randomized trial to evaluate the efficacy of early (less than or equal to 72 hours) versus late (10 to 14 days) conversion from endotracheal intubation to percutaneous, dilatational, translaryngeal tracheostomy for mechanical ventilation of traumatic brain injured patients. The primary efficacy parameter will be the number of days on mechanical ventilation. Secondary objectives include: * Number of days in the hospital * To assess the incidence of ventilator-acquired pneumonia in each group * To assess the incidence of accidental extubation in each group * To assess the incidence of death in each group

Conditions

• Respiratory Failure
• Traumatic Brain Injury

Interventions

Type	Name	Description
PROCEDURE	Early tracheostomy	early conversion - less than or equal to 72 hours
PROCEDURE	Late tracheostomy	Late conversion (10-14 days)

Timeline

• Start date: 2006-02-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2006-02-15
• Last updated: 2008-06-05

Locations

1 site across 1 country: United States