Document Classification

Section Type: METHODS

Text: The non-sedation (NONSEDA) trial is an investigator-initiated, randomised, clinical, parallel-group, multinational trial designed to include 700 patients from at least six ICUs in Denmark, Norway and Sweden. Inclusion criteria are mechanically ventilated patients with expected duration of mechanical ventilation > 24 hours. Exclusion criteria are non-intubated patients, patients with severe head trauma, coma at admission or status epilepticus, patients treated with therapeutic hypothermia, patients with PaO2/FiO2 < 9 where sedation might be necessary to ensure sufficient oxygenation or place the patient in prone position. Experimental intervention is non-sedation supplemented with pain management during mechanical ventilation. Control intervention is sedation with a daily wake-up trial. The primary outcome will be all cause mortality at 90 days after randomization.