Effect of early tracheostomy for determining patient outcomes vis-a-vis late tracheostomy in severe stroke patients: A randomized controlled trial.

Introduction: Stroke is a leading cause of mortality and disability in India, and the hospital and intensive care unit (ICU) beds are limited. This randomized controlled trial (RCT) aimed to assess the effectiveness of early tracheostomy (ET) in reducing 30-day mortality in stroke patients, and secondary objectives included evaluating rates of ventilator-associated pneumonia (VAP) and length of ICU stay compared to late tracheostomy (LT). Methods: This open-label RCT was conducted over 18 months at a tertiary care hospital in north India, involving 60 patients (30 in each group). Eligible participants were adults (≥18 years) with nontraumatic stroke (acute ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, and vasculitic infarcts) requiring prolonged intubation (stroke-related early tracheostomy score ≥8). Exclusions included preexisting pneumonia, high oxygen needs, pregnancy, and those on ventilation for over 4 days. Patients were assigned to ET (day 4) or LT (day 10), with demographics and clinical characteristics recorded. Mortality was assessed on day 30 postintubation and data for secondary outcomes were collected every other day. Results: Sixty-four patients were randomized, 30 to the ET group, and 34 to the LT group, with a mean age of 55.48 (±15.94) years. Mortality within 30 days was 50% in both groups. VAP rates were 43.3% in the ET group and 50% in the LT group ( Conclusion: The RCT found no significant differences in mortality or VAP rates but noted reduced ICU hospital stays for the ET group, suggesting benefits for severe stroke patients.