[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638344":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":22,"centralContacts":23,"locations":29,"responsibleParty":60,"collaborators":22,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":22,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":22,"enrollmentInfo":71,"targetDuration":22,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":86,"whyStopped":22,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Mahidol University","OTHER",[8,13],{"label":9,"type":10,"description":9,"interventionNames":11},"Decreased mental status","ACTIVE_COMPARATOR",[12],"Other: Processed EEG monitoring",{"label":14,"type":15,"description":14,"interventionNames":16},"Normal mental status","PLACEBO_COMPARATOR",[12],[18],{"type":6,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"Processed EEG monitoring","Monitor processed EEG using BIS",[9,14],null,[24],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Annop Piriyapatsom, M.D.","CONTACT","+66 2419 7990","annop.pir@mahidol.ac.th",[30],{"facility":31,"status":22,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University","Bangkok Noi","Bangkok","10700","Thailand","TH",{"type":38,"coordinates":39},"Point",[40,41],100.47798,13.76266,{"lat":41,"lon":40},[44,45,47,50,52,54,56,58],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},{"name":25,"role":46,"phone":22,"phoneExt":22,"email":22},"PRINCIPAL_INVESTIGATOR",{"name":48,"role":49,"phone":22,"phoneExt":22,"email":22},"Chatchawan Uacharuporn, M.D.","SUB_INVESTIGATOR",{"name":51,"role":49,"phone":22,"phoneExt":22,"email":22},"Tanuwong Viarasilpa, M.D.",{"name":53,"role":49,"phone":22,"phoneExt":22,"email":22},"Nattachai Hemtanon, M.D.",{"name":55,"role":49,"phone":22,"phoneExt":22,"email":22},"Suchanun Lao-amornphunkul, M.D.",{"name":57,"role":49,"phone":22,"phoneExt":22,"email":22},"Natthicha Papbamnarn, M.D.",{"name":59,"role":49,"phone":22,"phoneExt":22,"email":22},"Chayanan Thanakiattiwibun",{"type":61,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100638344","bis-in-critically-ill-patients-in-icu-100638344",false,"NCT07583732","BIS in Critically Ill Patients in ICU","The Comparison of Bispectral Index Parameter Between Critically Ill Patients With and Without Decreased Mental Status and Its Association With Clinical Outcomes","Inclusion Criteria:\n\n1. Age≥18years\n2. RASS score ≤ -3 as case\n3. RASS score 0 to -1 as control\n4. Expected ICU length of stays ≥ 24hours\n\nExclusion Criteria:\n\n1. Contraindication for BIS monitoring (wound or infection at forehead)\n2. No space for attach BIS monitoring at forehead\n3. Patient with sedative drugs (Propofol, Midazolam, Dexmedetomidine)\n4. Patient with acute stroke\n5. Patient was already on EEG monitoring\n6. Denied by patients or patient's surrogates","ALL","18 Years",{"count":72,"type":73},40,"ESTIMATED","INTERVENTIONAL",[76],"NA","The Bispectral Index (BIS) is a monitor that converts brain electrical activity from EEG into a simple number from 0 to 100. A higher number means the patient is more awake, while a lower number means deeper sedation or reduced brain activity.\n\nIn general, 100 means fully awake, 80 suggests light to moderate sedation, 60 is commonly used as a target for general anesthesia with a low chance of awareness, 40 indicates deep anesthesia, 20 suggests marked brain suppression with burst suppression on EEG, and 0 indicates no detectable cortical electrical activity.\n\nAlthough BIS was originally developed for use in the operating room, it has also been applied in the ICU to help guide sedation, avoid over- or under-sedation, and assess consciousness in patients who cannot be evaluated reliably using standard clinical scores. BIS has also been studied as a possible tool for predicting outcomes in comatose ICU patients, such as those after cardiac arrest, stroke, encephalitis, or traumatic brain injury. However, evidence is still limited for its use in predicting outcomes among ICU patients with any form of decreased consciousness. Therefore, this study was conducted to explore that role.",[79],"Critically Ill Patients",[81,82,83,84,85],"BIS","processed EEG","ICU patient","Sedation","Neuromonitoring","NOT_YET_RECRUITING","2026-05-06",{"date":89,"type":90},"2026-05-13","ACTUAL",{"date":92,"type":73},"2026-05-15",{"date":94,"type":73},"2027-03-31",{"name":5,"class":6},1]