Comparison of Effect of Early Versus Late Tracheostomy on outcomes in Severe Traumatic Brain Injury: A Randomized Controlled Study

This is a prospective, open-label, randomized controlled trial conducted at a tertiary care center to compare the effect of early versus late tracheostomy on clinical outcomes in patients with severe traumatic brain injury that is GCS less than or equal to 8. Eligible patients anticipated to require mechanical ventilation for more than 72 hours will be randomized into two groups- early tracheostomy performed on Day 3 and late tracheostomy performed on Day 5 of mechanical ventilation. The primary outcome is duration of mechanical ventilation. Secondary outcomes include incidence of ventilator-associated pneumonia, length of ICU and hospital stay, Glasgow Outcome Scale at discharge, tracheostomy-related complications, and 30-day mortality. The study aims to generate evidence to guide optimal timing of tracheostomy in severe head injury patients.