The purpose of this Expanded Access Protocol is to provide access to inhaled isoflurane delivered via the Sedaconda ACD-S device for sedation of adult patients in the ICU that are mechanically ventilated and are difficult to sedate with current available treatment options, and who, in the opinion of their treating physician, would benefit from this treatment.
Adults ≥18 years of age;
Receiving invasive mechanical ventilation and continuous sedation in the ICU;
Inability to maintain a target sedation level ensuring patient comfort and safety with conventional intravenous sedatives, in clinically appropriate combinations and at maximum tolerated doses, despite optimized analgesia and ventilator settings, with
recurring episodes of agitation or self-harm, such as attempting or actual removal of an endotracheal tube or of indwelling catheters or monitors, or necessitating physical restraints; or
Ventilator tidal volume <200 or >1000 mL
Need for high frequency oscillation ventilation (HFOV) or high frequency percussive ventilation (HFPV)
Comfort care only (end of life care);
Suspected but unmonitored elevated intracranial pressure (e.g., patients with acute stroke, severe head trauma, meningitis without ICP monitoring);