[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536774":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":36,"responsibleParty":87,"collaborators":90,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":103,"maxAge":12,"enrollmentInfo":104,"targetDuration":12,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":39,"whyStopped":12,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control arm","NO_INTERVENTION","Blinded data collection by the WARD-CSS without vital signs and active alerts displayed to the ward staff",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Intervention arm","EXPERIMENTAL","Monitoring by the WARD-CSS including vital signs and active alerts relayed to the nurses' smartphones during hospitalization",[18],"Device: WARD-CSS",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","WARD-CSS","Patients' continuously monitored vital signs will be recorded via a bedside tablet device (data not visible).\n\nThe clinical staff will have access to the continuously monitored vital signs through a mobile device (smart phone) with a purpose-built app-based GUI displaying vital sign status and summaries, alarms, and device connectivity. The GUI will alert the clinical staff (acoustic and visual signals) when any of the predefined thresholds for deviating vital signs are exceeded.",[14],[26],"Continuous vital signs monitoring with real-time alerts",[28],{"name":29,"affiliation":5,"role":30},"Jesper Mølgaard, PhD","PRINCIPAL_INVESTIGATOR",[32],{"name":29,"role":33,"phone":34,"phoneExt":12,"email":35},"CONTACT","+4535453545","moelgaard.jesper@gmail.com",[37,58,70],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Copenhagen University hospital - Rigshospitalet","RECRUITING","Copenhagen","Other (Non US)","1665","Denmark","DK",{"type":46,"coordinates":47},"Point",[48,49],12.56553,55.67594,{"lat":49,"lon":48},[52,54],{"name":29,"role":33,"phone":34,"phoneExt":12,"email":53},"jesper.moelgaard@regionh.dk",{"name":55,"role":33,"phone":56,"phoneExt":12,"email":57},"Eske K Aasvang, DMSc","+4535450802","eske.kvanner.aasvang.01@regionh.dk",{"facility":59,"status":39,"city":40,"state":41,"zip":60,"country":43,"countryCode":44,"cosmosGeoPoint":61,"geoPoint":63,"contacts":64},"Bispebjerg Hospital","2400",{"type":46,"coordinates":62},[48,49],{"lat":49,"lon":48},[65,69],{"name":66,"role":33,"phone":67,"phoneExt":12,"email":68},"Christian S Meyhoff, PhD","+4524910542","christian.sylvest.meyhoff@regionh.dk",{"name":66,"role":30,"phone":12,"phoneExt":12,"email":12},{"facility":71,"status":72,"city":73,"state":41,"zip":74,"country":43,"countryCode":44,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Hvidovre Hospital","NOT_YET_RECRUITING","Hvidovre","2650",{"type":46,"coordinates":76},[77,78],12.47708,55.64297,{"lat":78,"lon":77},[81,85],{"name":82,"role":33,"phone":83,"phoneExt":12,"email":84},"Katja B L Glud, RN","+4538625713","katja.balle.levring.glud@regionh.dk",{"name":86,"role":30,"phone":12,"phoneExt":12,"email":12},"Søren Kjær, MD",{"type":30,"investigatorFullName":88,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Jesper Mølgaard","MD, PhD, Principal investigator",[91,92],{"name":59,"class":6},{"name":93,"class":6},"Hvidovre University Hospital","100536774","postoperative-complications-in-cancer-patients-monitored-with-intelligent-continuous-monitoring-system-100536774",false,"NCT06269198","Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System","Postoperative Complications in Cancer Patients Monitored With Intelligent Continuous Monitoring System Versus Standard of Care - a Randomized Clinical Trial","WARD-SX-RCT-II","Inclusion Criteria:\n\n* Admission for elective major abdominal (gastrointestinal, gynecological, or urological) surgery with the primary aim of radical surgery\u002Fremoving suspected cancer tissue.\n* At least two expected postoperative admission days\n* Laparotomy or laparoscopy procedure estimated to last more than 2 hours.\n* Co-enrolment of patients in other studies is acceptable but in studies involving interventions which potentially will affect the continuous monitoring of vital signs and\u002For the primary or secondary outcomes, an assessment of whether these patients can be co-enrolled in the WARD-RCT should be conferred with the WARD RCT steering committee.\n\nExclusion Criteria:\n\n* Patient expected not to cooperate with study procedures\n* Allergy to study materials (silicone, plaster)\n* Impaired cognitive function (in uncertain cases assessed by a Mini Mental State Examination score \\\u003C 24). (Protocol Appendix E)\n* Patients with a pacemaker or Implantable Cardioverter Defibrillator (ICD) device\n* Inability to give informed consent\n* Patients with planned hyperthermic intraperitoneal chemotherapy (HIPEC) procedure or two-stage resections (two-stage hepatectomy, two-stage resection of malignant colorectal obstructions, etc.)","ALL","18 Years",{"count":105,"type":106},504,"ESTIMATED","INTERVENTIONAL",[109],"NA","The primary objective of this study is to determine the effect on complication severity of using a clinical monitoring system with automatic vital sign alerts in addition to routine monitoring versus routine monitoring alone in high-risk postoperative cancer patients within 30 days after surgery.\n\nOther objectives include documentation of the severity of complications within seven days of surgery, frequency of serious adverse events, mortality, length of stay and delay of planned chemotherapy.",[112,113],"Postoperative Complications","Cancer, Treatment-Related",[115,116,117,118,119],"vital signs","continuous monitoring","wireless monitoring","postoperative physiology","postoperative complications","2025-01-13",{"date":122,"type":123},"2025-01-15","ACTUAL",{"date":125,"type":123},"2023-10-31",{"date":127,"type":106},"2027-04-01",{"name":5,"class":6},3]