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University","Richmond","Virginia","23284",{"type":43,"coordinates":185},[186,187],-77.46026,37.55376,{"lat":187,"lon":186},{"type":190,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100464407","phase-3-efficacy-and-safety-of-inhaled-isoflurane-delivered-via-the-sedaconda-acd-s-compared-to-intravenous-propofol-for-sedation-of-mechanically-ventilated-intensive-care-unit-adult-patients-inspire-icu2-100464407",true,"NCT05327296","Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU2)","A Phase 3, Multicenter, Randomized, Controlled, Open Label, Assessor-Blinded Study to Evaluate the Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients 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MH;\n* Severe hemodynamic compromise, defined as the need for norepinephrine ≥0.3 mcg\u002Fkg\u002Fmin (or equivalent vasopressor dose) to maintain blood pressure within acceptable range, assumed to be mean arterial pressure ≥65 mmHg unless prescribed clinically;\n* Allergy to isoflurane or propofol, or have propofol infusion syndrome.\n* History of ventricular tachycardia\u002FLong QT Syndrome;\n* Requirement of IV benzodiazepine or barbiturate administration for seizures or dependencies, including alcohol withdrawal\n* Neuromuscular disease that impairs spontaneous ventilation (eg, C5 or higher spinal cord injury, amyotrophic lateral sclerosis, etc);\n* Concurrent enrollment in another study that, in the Investigator's opinion, would impact the patient's safety or assessments of this study;\n* Participation in other study involving investigational drug(s) or devices(s) within 30 days prior to Randomization;\n* Anticipated requirement of treatment with continuous infusion of a neuromuscular blocking agent for \\>4 hours;\n* Female patients who are pregnant or breast-feeding;\n* Imperative need for continuous active humidification through mechanical ventilation circuit;\n* Attending physician's refusal to include the patient; or\n* Inability to obtain informed consent.",false,"ALL","18 Years",{"count":203,"type":204},282,"ACTUAL","INTERVENTIONAL",[207],"PHASE3","This is a study to compare safety and efficacy of inhaled isoflurane administered via the Sedaconda ACD-S device system versus intravenous propofol for sedation of mechanically ventilated patients in the Intensive Care Unit (ICU) setting.",[210],"Sedation",[212,213,214,215,216],"sedation","mechanical ventilation","propofol","ICU","isoflurane","COMPLETED","2026-03-03",{"date":220,"type":204},"2026-03-24",{"date":222,"type":204},"2022-06-30",{"date":224,"type":204},"2024-11-14",{"name":5,"class":6},16]