protocolSection identificationModule nctId: NCT06293170, orgStudyIdInfo id: 2024-DETECTIVENEUROLOGYUKD0001, briefTitle: Automated Screening for Clinically Ascertained Loss of Cerebral Functions, acronym: DETECT-IVE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-11-01, completionDateStruct date: 2026-11-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Technische Universität Dresden, class: OTHER, descriptionModule briefSummary: Rationale: The low organ donation rate in Germany is associated with the inadequate identification of patients at risk of developing irreversible loss of brain function (ILBF; i.e. brain death). An automated digital screening tool, DETECT (AutomateD ScrEening for Clinically AscerTainEd Loss of Cerebral FuncTions in Patients with Severe Brain Damage), has been developed to prospectively identify intensive care patients who are at risk of developing ILBF.Objective: The objective of the study is to evaluate the effectiveness of an automated digital screening tool in the identification of patients with severe brain damage who are at risk of impending ILBF compared to standard practice without digital support.Study design: Stepped-Wedge, multicenter, cluster-randomized, controlled trialStudy population: The study includes patients aged 18 years or older with primary and/or secondary acute brain damage, requiring mechanical ventilation, and who are deceased upon hospital discharge.Intervention: DETECT periodically processes real-time data from the corresponding electronic medical record system to screen for a combination of coma, indicated by a Richmond Agitation Sedation Scale (RASS) score of - 4 or - 5 or Glasgow Coma Scale (GCS) score of 6-3, along with manually assessed absence of bilateral pupillary light reflexes. Both findings are considered early indicators of impending ILBF. In case of positive screening results, an automated notification will be sent via the hospital's email server to the corresponding transplant coordinators and intensivists. The email sent aims to prompt clinical assessment of the reported patient and, if necessary, initiate a guideline-based ILBF examination.Primary study endpoint: The primary endpoint is the identification of patients who eventually develop ILBF during hospitalization.Secondary study endpoints: Secondary outcomes encompass the missed identification of potential ILBF cases (as retrospectively classified) and the rate of deceased organ donations. Upon completion of the study, a survey will be conducted to investigate the stakeholders' experiences with DETECT., conditionsModule conditions: Irreversible Loss of Brain Function (ILBF), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: SCREENING, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 4800, type: ESTIMATED, armsInterventionsModule interventions name: DETECT, interventions name: Conventional care, outcomesModule primaryOutcomes measure: Number of patients with diagnosis of ILBF, secondaryOutcomes measure: Number of patients who undergo deceased organ donation, secondaryOutcomes measure: Number of patients in whom diagnosis of ILBF was missed, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, city: Dresden, zip: 01307, country: Germany, contacts name: Kristian Barlinn, MD, role: CONTACT, phone: +49 (0)351 458 3565, email: kristian.barlinn@ukdd.de, geoPoint lat: 51.05089, lon: 13.73832, hasResults: False