6/28/23, 11:22 PM NONSEDA Pathway Feedback Search Clinical Topics Home Studies NONSEDA NONSEDA Trial question Is nonsedation superior to light sedation in mechanically ventilated patients? Study design Multi-center Open label RCT Population Characteristics of study participants 46.2% female N = 700 53.8% male 700 patients (126 female, 147 male) Inclusion criteria: patients undergoing mechanical ventilation in the ICU Key exclusion criteria: severe head trauma, therapeutic hypothermia, status epilepticus, sedation anticipated to be necessary for oxygenation Interventions N=349 no sedation (no regular sedatives) N=351 light sedation (target RASS -2 to -3) Primary outcome Death at 90 days 42.4 % 42.4 37 31.8 % 21.2 % 10.6 % No significant difference 0.0 % https://web.pathway.md/studies/reclbA9aL2DF3CyBw 1/2 6/28/23, 11:22 PM NONSEDA Pathway No sedation Light sedation No significant difference in death at 90 days (42.4% vs. 37%; ARD 5.4, 95% CI -2.2 to 12.2) Secondary outcomes No significant difference in days alive at 90 days (13 days vs. 12 days; ARD 1, 95% CI -2 to 5) Borderline significant increase in coma and delirium-free days (27 days vs. 26 days; ARD 1, 95% CI 0 to 2) No significant difference in ventilator-free days (20 days vs. 19 days; ARD 1, 95% CI -3 to 3) Safety outcomes No significant differences in accidental extubation leading to intubation within 1 hour (1.1% vs. 0.3%, p=0.20). Conclusion In patients undergoing mechanical ventilation in the ICU, no sedation was not superior to light sedation with respect to death at 90 days. Reference Hanne T Olsen, Helene K Nedergaard, Thomas Str m et al. Nonsedation or Light Sedation in Critically Ill, Mechanically Ventilated Patients. N Engl J Med. 2020 Mar 19;382(12):1103-1111. Open reference URL https://web.pathway.md/studies/reclbA9aL2DF3CyBw 2/2