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City","Utah","84111",{"type":48,"coordinates":157},[158,159],-111.89105,40.76078,{"lat":159,"lon":158},{"facility":162,"status":26,"city":163,"state":164,"zip":165,"country":45,"countryCode":46,"cosmosGeoPoint":166,"geoPoint":170,"contacts":26},"University of Virginia","Charlottesville","Virginia","22903",{"type":48,"coordinates":167},[168,169],-78.47668,38.02931,{"lat":169,"lon":168},{"type":172,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100463260","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-icu1-100463260",true,"NCT05312385","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-ICU1)","A Phase 3, 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(ECMO), extracorporeal CO2 removal (ECCO2R), high frequency oscillation ventilation (HFOV), or high frequency percussive ventilation (HFPV) at Screening;\n* Comfort care only (end of life care);\n* Contraindication to propofol or isoflurane;\n* Known or family history of 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":185,"type":186},277,"ACTUAL","INTERVENTIONAL",[189],"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.",[192],"Sedation",[194,195,196,197,198],"sedation","mechanical 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