[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505906":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":101,"collaborators":103,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":109,"sex":115,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":18,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":18,"overallStatus":38,"whyStopped":18,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Sunnybrook Health Sciences Centre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Inhaled sedation - volatile anesthetic","EXPERIMENTAL","The ICU patient will receive Isoflurane. Dosage will be modified as per health care team guidance for the best treatment of the participant.",[13],"Drug: Isoflurane Inhalant Product",{"label":15,"type":16,"description":17,"interventionNames":18},"IV sedation - standard of care","NO_INTERVENTION","The ICU patient will receive standard of care, which is IV sedation supplied by the hospital. Dosage will be modified as per health care team guidance for the best treatment of the participant.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Isoflurane Inhalant Product","Isoflurane will be administered using an inhalation device",[9],[26],{"name":27,"affiliation":5,"role":28},"Angela Jerath, MD","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Sunnybrook Research Institute, Program Manager - Centre for Clinical Trials Services","CONTACT","416-480-6100","ABOVETrial@sunnybrook.ca",[36,61,81],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"McMaster Children's Hospital","RECRUITING","Hamilton","Ontario","L8N 3Z5","Canada","CA",{"type":45,"coordinates":46},"Point",[47,48],-79.84963,43.25011,{"lat":48,"lon":47},[51,56,59],{"name":52,"role":32,"phone":53,"phoneExt":54,"email":55},"Sherrie Orr","905-521-2100","75824","orrs@mcmaster.ca",{"name":57,"role":32,"phone":18,"phoneExt":18,"email":58},"Marina Mir-Parramon","mirparrm@mcmaster.ca",{"name":60,"role":28,"phone":18,"phoneExt":18,"email":18},"Marina Mir-Parramon, MD",{"facility":62,"status":38,"city":63,"state":40,"zip":64,"country":42,"countryCode":43,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Children's Hospital - London Health Sciences Centre","London","N6A 5W9",{"type":45,"coordinates":66},[67,68],-81.23304,42.98339,{"lat":68,"lon":67},[71,76,79],{"name":72,"role":32,"phone":73,"phoneExt":74,"email":75},"Maysaa Assaf","519-685-8500","77548","Maysaa.Assaf@lhsc.on.ca",{"name":77,"role":32,"phone":18,"phoneExt":18,"email":78},"Rishi Ganesan","Rishi.Ganesan@lhsc.on.ca",{"name":80,"role":28,"phone":18,"phoneExt":18,"email":18},"Rishi Ganesan, MD, DM",{"facility":82,"status":38,"city":83,"state":40,"zip":84,"country":42,"countryCode":43,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"The Hospital for Sick Children (SickKids)","Toronto","M5G 1X8",{"type":45,"coordinates":86},[87,88],-79.39864,43.70643,{"lat":88,"lon":87},[91,96,99],{"name":92,"role":32,"phone":93,"phoneExt":94,"email":95},"Stephanie DeLorenzo","416-813-7654","414712","stephanie.delorenzo@sickkids.ca",{"name":97,"role":32,"phone":18,"phoneExt":18,"email":98},"Nicole McKinnon","nicole.mckinnon@sickkids.ca",{"name":100,"role":28,"phone":18,"phoneExt":18,"email":18},"Nicole McKinnon, MD, PhD",{"type":102,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[104],{"name":105,"class":106},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV","100505906","phase-3-advancing-brain-outcomes-in-pediatric-critically-ill-patients-sedated-with-volatile-anesthestic-agents-100505906",false,"NCT05867472","Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents","Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents: A Pilot Multicentre Randomized Controlled Trial","ABOVE","Inclusion Criteria:\n\n1. Pediatric patients age from 1 month to less than 18 years who need sedation to tolerate mechanical ventilation and will remain ventilated for ≥ 24 hours\n2. Receiving IV sedation by infusion or bolus for ≤72h to aid mechanical ventilation (but will be recruited as early as possible)\n\nExclusion Criteria:\n\n1. Current use of inhaled prostacyclin (high viscosity of prostacyclin impairs vaporizer device) or continuous salbutamol nebulization (impairs gas analyzer function)\n2. Family history or personal history of malignant hyperthermia (MH)\n3. Allergy to isoflurane, sevoflurane or other volatile inhaled anesthetic gas\n4. Metabolic, mitochondrial or myopathy disease e.g., Duchenne muscular dystrophy (volatiles may trigger malignant hyperthermia like reaction)\n5. Moribund with expected survival \\\u003C 24h\n6. Known pregnancy or lactation\n7. Suspected or evidence of high intracranial pressure (ICP)\n8. Not a 'closed ventilator circuit' with potential for gas leak (e.g. uncuffed ETT, bronchopleural fistula, tracheal\u002Ftrachea-esophageal fistulas, or other sources of \"gas leak\" from patient circuit that cannot be removed)\n9. Prior enrollment in the ABOVE trial","ALL","1 Month","18 Years",{"count":119,"type":120},60,"ESTIMATED","INTERVENTIONAL",[123],"PHASE3","The goal of a pilot study is to test a study plan to see if it is appropriate for a larger study. This study plan is looking at whether the use of inhaled sedatives (medications that help people be calm and sleep) can reduce delirium (extreme confusion) in children who need a ventilator (breathing machine) compared to IV or oral sedatives.\n\nThe main question\\[s\\] it aims to answer are:\n\n* Will people join the study? (recruitment)\n* Will participants finish the study?\n* Will healthcare teams accept the study procedures?\n\nParticipants will be randomized to receive study treatment (inhaled sedation) or standard of care (IV sedation). They will be monitored daily for up to 28 days. They will complete memory, thinking and behaviour tasks after 9-12 months.",[126,127,128],"Intensive Care Units, Pediatric","Anesthetics, Inhalation","Mechanically Ventilated, Critically Ill Children","2026-02-02",{"date":131,"type":132},"2026-02-04","ACTUAL",{"date":134,"type":132},"2023-10-10",{"date":136,"type":120},"2026-12",{"name":5,"class":6},3]