Expanded Access for Inhaled Isoflurane Delivered Via the Sedaconda ACD-S for Sedation of Difficult-to-Sedate Adult Mechanically Ventilated Intensive Care Unit Patients

Inclusion Criteria

• •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
• •1. 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
• •2. escalating sedative and opioid drug doses, despite mitigating strategies (e.g., sedative drug combinations or rotation to reduce toxicity); or
• •3. clinical concerns for, or indications of, serious untoward effects of ongoing conventional intravenous sedation and analgesia agents (e.g., hypertriglyceridemia, propofol-related infusion syndrome, bradycardia, iatrogenic withdrawal syndrome); and
• •No other available sedative option is considered appropriate
• •Is not currently enrolled in or is eligible for a clinical study that would prohibit the participation in this EAP.