[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627498":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":35,"responsibleParty":57,"collaborators":18,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":18,"enrollmentInfo":68,"targetDuration":18,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":82,"whyStopped":18,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Ceribell Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Prospective Ceribell Delirium Monitoring","EXPERIMENTAL","ICU patients who meet the inclusion and exclusion criteria will be enrolled. These patients will undergo up to 12 hours of continuous EEG recording with the Ceribell Delirum Monitor for up to 7 days. If delirium is detected, the study staff will perform CAM-ICU assessments to determine the presence of delirium. Additionally, a Delirium Trend Report will be presented to each patient's care team during morning rounds and any alterations in patient care will be documented.",[13],"Device: Ceribell Delirium Monitoring System",{"label":15,"type":16,"description":17,"interventionNames":18},"Retrospective Control","NO_INTERVENTION","Patients who met the inclusion and exclusion criteria during their ICU stay will be enrolled in the retrospective control arm. Study staff will collect data on delirium management and patient clinical outcomes from chart review.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Ceribell Delirium Monitoring System","The Ceribell Delirium Monitor provides an assessment of delirium every 15 minutes during each EEG recording and provides a trend graph depicting the output of the algorithm. If delirium is detected, a CAM-ICU assessment will be performed to confirm the presence of delirium. The patient's care team will use the additional data provided by the Ceribell Delirium Monitor to inform decisions regarding alterations in the patient's delirium management.",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Michelle Hofmann, MSN","CONTACT","908-892-1193","michelle.hofmann@ceribell.com",{"name":32,"role":28,"phone":33,"phoneExt":18,"email":34},"Alexandra C. Fietsam, PhD","563-209-1704","courtney.fietsam@ceribell.com",[36],{"facility":37,"status":18,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"University of California Irvine","Irvine","California","92697","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-117.82311,33.66946,{"lat":47,"lon":46},[50,54],{"name":51,"role":28,"phone":52,"phoneExt":18,"email":53},"Masih Rafi, MD","949-824-7281","mrafi@uci.edu",{"name":55,"role":56,"phone":18,"phoneExt":18,"email":18},"Yama Akbari, MD, PhD","PRINCIPAL_INVESTIGATOR",{"type":58,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100627498","ceribell-delirium-monitor-outcomes-pilot-study-100627498",false,"NCT07449416","Ceribell Delirium Monitor Outcomes Pilot Study","DOM","Inclusion Criteria:\n\n* Age is 18 years or older\n* Admitted to the ICU for an expected duration ≥ 24 hours from enrollment\n* Have at least one of the following conditions:\n\nAcute Sepsis or Septic Shock Admitted to the ICU following elective cardiothoracic surgery Acute respiratory failure requiring non-invasive ventilation or high-flow nasal cannula (HFNC) oxygenation Shock requiring vasopressor therapy Mechanically ventilated - Current RASS ≥ -3 and not expected to require deep sedation (RASS \\\u003C -3) during the ICU stay\n\nExclusion Criteria:\n\n\\- Any structural abnormality or head condition, including the presence of a device, that would prevent the use of the Ceribell EEG system for the entire anticipated EEG monitoring period. Examples include: Craniectomy with a missing bone flap in a region where Ceribell EEG electrodes would be placed.\n\nAnticipated use of continuous EEG for a purpose other than delirium detection during the entire expected monitoring period.\n\n* Baseline neurological dysfunction (Glasgow Coma Scale \\\u003C 10) and pre-existing brain injuries such as stroke with known deficits, severe TBI\n* History of moderate-severe dementia (IQCODE ≥ 3.5)\n* APACHE II score \\> 30, or SOFA \\> 9 at enrollment","ALL","18 Years",{"count":69,"type":70},100,"ESTIMATED","INTERVENTIONAL",[73],"NA","This pilot study is designed as a pre- and post-delirium monitor cohort study, with a prospective intervention cohort and a retrospective control cohort.",[76],"Delirium in the Intensive Care Unit",[78,79,80,81],"Delirium","Delirium Monitoring","Ceribell","Electroencephalogram (EEG)","NOT_YET_RECRUITING","2026-02-27",{"date":85,"type":86},"2026-03-04","ACTUAL",{"date":88,"type":70},"2026-03-15",{"date":90,"type":70},"2026-12",{"name":5,"class":6},1]