[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100463958":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":34,"responsibleParty":125,"collaborators":127,"id":131,"slug":132,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":133,"sex":139,"minAge":140,"maxAge":10,"enrollmentInfo":141,"targetDuration":10,"studyType":144,"phases":10,"briefSummary":145,"conditions":146,"keywords":150,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Comatose patients in intensive care unit",null,"Patient admitted in the intensive care unit (ICU) for post cardiac arrest (CA) coma, persistent for at least 3 days after CA.",[13],"Other: Neurological prognosis",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"Neurological prognosis","In usual practice, in intensive care unit, evaluating the neurological prognosis of comatose patients after cardiac arrest requires a multimodal approach combining standardized clinical examination, serum biomarkers, imaging and classically electrophysiological examinations (among them auditive evoked potentials or AEP).\n\nAn algorithm (PRECOM tool) which has been previously developed from the signal extracted from AEP allows to visually classify the patients after processing signal by the algorithm in a cluster of points with a high specificity into \"good neurological prognosis\" and \"bad neurological prognosis\".\n\nThe AEP signals recorded in the 1st and 2nd week of patient inclusion are to be collected by the neurophysiologist. At the end of the patient's participation in the study, these data will be encrypted, anonymized and transmitted to the mathematician to be processed by the PRECOM tool.",[9],[20],{"name":21,"affiliation":22,"role":23},"Nathalie KUBIS, Md,PhD","APHP Lariboisière Hospital, Clinical Physiology Department","STUDY_DIRECTOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Nathalie KUBIS, Md, PhD","CONTACT","+33(0)149958324","nathalie.kubis@aphp.fr",{"name":31,"role":27,"phone":32,"phoneExt":10,"email":33},"Romain SONNEVILLE, Md, PhD","+33(0)140256139","romain.sonneville@aphp.fr",[35,55,64,76,88,99,111],{"facility":36,"status":37,"city":38,"state":10,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"APHP Avicenne Hospital - Réanimation médico-chirurgicale","RECRUITING","Bobigny","93000","France","FR",{"type":43,"coordinates":44},"Point",[45,46],2.45012,48.90982,{"lat":46,"lon":45},[49,53],{"name":50,"role":27,"phone":51,"phoneExt":10,"email":52},"Johanna OZIEL, Ph","+33 1 48 95 52 41","johanna.oziel@aphp.fr",{"name":50,"role":54,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"facility":22,"status":56,"city":57,"state":10,"zip":58,"country":40,"countryCode":41,"cosmosGeoPoint":59,"geoPoint":63,"contacts":10},"ACTIVE_NOT_RECRUITING","Paris","75010",{"type":43,"coordinates":60},[61,62],2.3488,48.85341,{"lat":62,"lon":61},{"facility":65,"status":37,"city":57,"state":10,"zip":58,"country":40,"countryCode":41,"cosmosGeoPoint":66,"geoPoint":68,"contacts":69},"APHP Laribosière Hospital - Service de Réanimation Médical et Toxicologique",{"type":43,"coordinates":67},[61,62],{"lat":62,"lon":61},[70,74],{"name":71,"role":27,"phone":72,"phoneExt":10,"email":73},"Bruno MEGARBANE, MD, PhD","+33 (0)1 49 95 64 91","bruno.megarbane@aphp.fr",{"name":75,"role":54,"phone":10,"phoneExt":10,"email":10},"Bruno MEGARBANE, Md, PhD",{"facility":77,"status":37,"city":57,"state":10,"zip":78,"country":40,"countryCode":41,"cosmosGeoPoint":79,"geoPoint":81,"contacts":82},"APHP Cochin Hospital - médecine intensive-réanimation","75014",{"type":43,"coordinates":80},[61,62],{"lat":62,"lon":61},[83,87],{"name":84,"role":27,"phone":85,"phoneExt":10,"email":86},"Sarah BENGHANEM, Ph","+33 1 58 41 25 33","sarah.benghanem@aphp.fr",{"name":84,"role":54,"phone":10,"phoneExt":10,"email":10},{"facility":89,"status":37,"city":57,"state":10,"zip":90,"country":40,"countryCode":41,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},"APHP HEGP hospital - Réanimation médicale","75015",{"type":43,"coordinates":92},[61,62],{"lat":62,"lon":61},[95,98],{"name":96,"role":27,"phone":10,"phoneExt":10,"email":97},"Jean-Luc DIEHL, Md,PhD","jean-luc.diehl@aphp.fr",{"name":96,"role":54,"phone":10,"phoneExt":10,"email":10},{"facility":100,"status":37,"city":57,"state":10,"zip":101,"country":40,"countryCode":41,"cosmosGeoPoint":102,"geoPoint":104,"contacts":105},"APHP Bichat Hospital -Médecine intensive - réanimation infectieuse","75018",{"type":43,"coordinates":103},[61,62],{"lat":62,"lon":61},[106,110],{"name":107,"role":27,"phone":108,"phoneExt":10,"email":109},"Marc DOMAN, Ph","+33 1 40 25 79 24","marc.doman@aphp.fr",{"name":107,"role":54,"phone":10,"phoneExt":10,"email":10},{"facility":112,"status":37,"city":113,"state":10,"zip":114,"country":40,"countryCode":41,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Delafontaine Hospital - médecine intensive-réanimation","Saint-Denis","93200",{"type":43,"coordinates":116},[117,118],2.35387,48.93564,{"lat":118,"lon":117},[121,124],{"name":122,"role":27,"phone":10,"phoneExt":10,"email":123},"Daniel DA SILVA, Md","daniel.silva@ch-stdenis.mssante.fr",{"name":122,"role":54,"phone":10,"phoneExt":10,"email":10},{"type":126,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[128],{"name":129,"class":130},"Ecole Normale Supérieure de Paris","UNKNOWN","100463958","predictive-outcome-in-comatose-patients-100463958",false,"NCT05321459","Predictive Outcome in Comatose Patients","New Predictive Tool of Awakening in Comatose Patients in the Intensive Care Unit","PRECOM","Inclusion Criteria:\n\n* Age above18 years old\n* Patient affiliated to a French Heath Care Insurance\n* Admitted in the intensive care unit (ICU) for coma post extra- or intra-hospital cardiac arrest (CA) with shockable or non-shockable rhythm\n* Persistent coma on day 3 after post CA, defined by the inability to respond to a verbal command in an appropriate manner (motor Glasgow components ≤ 3) and at the time of neurophysiological recordings (D3-D7 ± week -end).\n\nExclusion Criteria:\n\n* Decision to limit resuscitation therapies taken by the resuscitation team\n* Inability to perform the auditory evoked potentials (AEP) (deafness, skin lesion or any condition preventing to record AEP).\n* Opposition by the trusted person or by the patient once he\u002Fshe wakes up","ALL","18 Years",{"count":142,"type":143},100,"ESTIMATED","OBSERVATIONAL","Evaluating the prognosis of comatose patients after cardiac arrest (CA) in the intensive care unit (ICU) remains challenging. It requires a multimodal approach combining standardized clinical examination, serum biomarkers, imaging and classically electrophysiological examinations, (among them auditive evoked potentials or AEP) but none has a sufficient sensitivity\u002Fspecificity. In a preliminary study, the investigators developed an algorithm from the signal collected with AEP, and generated a probability map to visually classify the participants after the algorithm processing. Participants could be classified either with a good neurological prognosis or with bad neurological prognosis or death.\n\nThe investigators hypothesize that the \"PRECOM\" tool, applied blindly to a large prospective multicenter cohort of patients admitted to intensive care for coma in the aftermath of CA will predict neurological prognosis at 3 months with high sensitivity and specificity.",[147,148,149],"Coma","Heart Arrest","Cardiopulmonary Resuscitation",[151,152,153,154,155,156,157],"Post cardiac arrest for comatose patients","Electroencephalography","Somatosensory evoked potentials","Auditory evoked potentials","Prognosis","Algorithms","Classification","2025-12-16",{"date":160,"type":161},"2025-12-23","ACTUAL",{"date":163,"type":161},"2023-11-15",{"date":165,"type":143},"2028-05-29",{"name":5,"class":6},7]