Traumatic Brain Injury Clinical Trial
Official title:
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
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.
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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