6/29/23, 11:41 PM SETPOINT2 Pathway Feedback Search Clinical Topics Home Studies SETPOINT2 SETPOINT2 Disease Disease Disease Acute ischemic stroke Intracerebral hemorrhage Subarachn Trial question Is a strategy of early tracheostomy superior to the standard strategy in patients with severe stroke receiving mechanical ventilation? Study design Multi-center Open label RCT Population Characteristics of study participants 50.0% female N = 380 50.0% male 380 patients (189 female, 191 male) Inclusion criteria: patients with severe acute ischemic or hemorrhagic stroke receiving invasive ventilation Key exclusion criteria: premorbid mRS score > 1; invasive mechanical ventilation > 4 days; clinical condition either prohibiting early tracheostomy or mandating a surgical tracheostomy; pregnancy; life expectancy < 3 weeks Interventions N=188 early tracheostomy strategy (tracheostomy within 5 days of intubation) N=194 standard tracheostomy strategy (tracheostomy from day 10) https://web.pathway.md/studies/rec6h32GOYDNbxkmC 1/2 6/29/23, 11:41 PM SETPOINT2 Pathway Primary outcome Poor functional outcome as measured by a modified Rankin Scale score of < 4 at 6 months 47.1 % 47.1 43.5 35.3 % 23.6 % 11.8 % No significant difference 0.0 % Early tracheostomy strategy Standard tracheostomy strategy No significant difference in poor functional outcome as measured by a mRS score of < 4 at 6 months (43.5% vs. 47.1%; ARD -3.6, 95% CI -14.3 to 7.2) Secondary outcomes No significant difference in favorable functional outcome as measured by a mRS score of 0-3 at 6 months (24.3% vs. 19.6%; AD 4.7%, 95% CI -4.3 to 13.7) No significant difference in death in the ICU (14% vs. 14.9%; HR 0.94, 95% CI 0.65 to 1.35) No significant difference in time to discharge from hospital (24 days vs. 26 days; HR 0.94, 95% CI 0.76 to 1.18) Safety outcomes No significant difference in serious adverse events. Conclusion In patients with severe acute ischemic or hemorrhagic stroke receiving invasive ventilation, early tracheostomy strategy was not superior to standard tracheostomy strategy with respect to poor functional outcome as measured by a mRS score of < 4 at 6 months. Reference Julian B sel, Wolf-Dirk Niesen, Farid Salih et al. Effect of Early vs Standard Approach to Tracheostomy on Functional Outcome at 6 Months Among Patients With Severe Stroke Receiving Mechanical Ventilation: The SETPOINT2 Randomized Clinical Trial. JAMA. 2022 May 17;327(19):1899-1909. Open reference URL https://web.pathway.md/studies/rec6h32GOYDNbxkmC 2/2