[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518021":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":37,"responsibleParty":180,"collaborators":18,"id":183,"slug":184,"hasResults":185,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":185,"sex":191,"minAge":192,"maxAge":193,"enrollmentInfo":194,"targetDuration":18,"studyType":197,"phases":198,"briefSummary":200,"conditions":201,"keywords":205,"overallStatus":56,"whyStopped":18,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":221},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Early transnasal evaporative cooling with the RhinoChill device","EXPERIMENTAL","Early transnasal evaporative cooling initiated during ACLS at the scene of the cardiac arrest within 20 minutes from EMS arrival and subsequent hypothermia at 33ºC for 24 hours and fever control for 72 hours at the ICU",[13],"Device: Early transnasal evaporative cooling with the RhinoChill device",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of care","NO_INTERVENTION","Standard advanced cardiac life support, subsequent fever control (Normothermia) for 72 hours at ICU",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"DEVICE","Early prehospital transnasal evaporative cooling followed by systemic hypothermia to 33 degrees Celsius for 24 hours and fever control for 72 hours",[9],[25],{"name":26,"affiliation":5,"role":27},"Per Nordberg, MD, PhD","PRINCIPAL_INVESTIGATOR",[29,33],{"name":26,"role":30,"phone":31,"phoneExt":18,"email":32},"CONTACT","+46702802579","per.nordberg@ki.se",{"name":34,"role":30,"phone":35,"phoneExt":18,"email":36},"Emelie Dillenbeck, MD","+46736484567","emelie.dillenbeck@regionstockholm.se",[38,54,69,78,87,101,115,129,146,156,169],{"facility":39,"status":40,"city":41,"state":18,"zip":18,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"University Hospital Vienna","NOT_YET_RECRUITING","Vienna","Austria","AT",{"type":45,"coordinates":46},"Point",[47,48],16.37208,48.20849,{"lat":48,"lon":47},[51],{"name":52,"role":30,"phone":18,"phoneExt":18,"email":53},"Michael Holzer, MD, PhD","michael.holzer@meduniwien.ac.at",{"facility":55,"status":56,"city":57,"state":18,"zip":18,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"CHU Saint-Pierre","RECRUITING","Brussels","Belgium","BE",{"type":45,"coordinates":61},[62,63],4.34878,50.85045,{"lat":63,"lon":62},[66],{"name":67,"role":30,"phone":18,"phoneExt":18,"email":68},"Marie-Astrid de Villenfagne, PhD","marie-astrid.devillenfagne@stpierre-bru.be",{"facility":70,"status":56,"city":57,"state":18,"zip":18,"country":58,"countryCode":59,"cosmosGeoPoint":71,"geoPoint":73,"contacts":74},"Erasme University Hospital",{"type":45,"coordinates":72},[62,63],{"lat":63,"lon":62},[75],{"name":76,"role":30,"phone":18,"phoneExt":18,"email":77},"Fabio S Taccone, MD, PhD","fabio.taccone@ulb.be",{"facility":79,"status":56,"city":57,"state":18,"zip":18,"country":58,"countryCode":59,"cosmosGeoPoint":80,"geoPoint":82,"contacts":83},"Europe Hospitals St Elizabeth",{"type":45,"coordinates":81},[62,63],{"lat":63,"lon":62},[84],{"name":85,"role":30,"phone":18,"phoneExt":18,"email":86},"Michael Vandoorslaert, PhD","M.VANDOORSLAERT@europehospitals.be",{"facility":88,"status":56,"city":89,"state":18,"zip":18,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"University Hospital Freiburg","Freiburg im Breisgau","Germany","DE",{"type":45,"coordinates":93},[94,95],7.85222,47.9959,{"lat":95,"lon":94},[98],{"name":99,"role":30,"phone":18,"phoneExt":18,"email":100},"Hans-Jörg Busch, MD, PhD","hans-joerg.busch@uniklinik-freiburg.de",{"facility":102,"status":40,"city":103,"state":18,"zip":18,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Department of Anesthesiology, Intensive Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico","Milan","Italy","IT",{"type":45,"coordinates":107},[108,109],12.59836,42.78235,{"lat":109,"lon":108},[112],{"name":113,"role":30,"phone":18,"phoneExt":18,"email":114},"Giuseppe Ristagno, Prof","gristag@gmail.com",{"facility":116,"status":56,"city":117,"state":18,"zip":18,"country":118,"countryCode":119,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Ljubljana University Medical Centre","Ljubljana","Slovenia","SI",{"type":45,"coordinates":121},[122,123],14.50513,46.05108,{"lat":123,"lon":122},[126],{"name":127,"role":30,"phone":18,"phoneExt":18,"email":128},"Peter Radsel, MD","pradsel@gmail.com",{"facility":130,"status":56,"city":131,"state":18,"zip":18,"country":132,"countryCode":133,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Hospital Universitario La Paz","Madrid","Spain","ES",{"type":45,"coordinates":135},[136,137],-3.70256,40.4165,{"lat":137,"lon":136},[140,143],{"name":141,"role":30,"phone":18,"phoneExt":18,"email":142},"Sandra O Rosillo Rodríguez, PhD","sorrph17@gmail.com",{"name":144,"role":30,"phone":18,"phoneExt":18,"email":145},"Ervigio Corral Torres","corralte@madrid.es",{"facility":147,"status":56,"city":131,"state":18,"zip":18,"country":132,"countryCode":133,"cosmosGeoPoint":148,"geoPoint":150,"contacts":151},"San Carlos Clinical Hospital",{"type":45,"coordinates":149},[136,137],{"lat":137,"lon":136},[152,154],{"name":153,"role":30,"phone":18,"phoneExt":18,"email":18},"Miguel Sanchez, PhD",{"name":155,"role":30,"phone":18,"phoneExt":18,"email":18},"Juan Carlos Martín Benítez, PhD",{"facility":157,"status":56,"city":158,"state":18,"zip":18,"country":159,"countryCode":160,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Karolinska University Hospital","Stockholm","Sweden","SE",{"type":45,"coordinates":162},[163,164],18.06871,59.32938,{"lat":164,"lon":163},[167],{"name":168,"role":30,"phone":18,"phoneExt":18,"email":32},"Per Nordberg, PhD",{"facility":170,"status":56,"city":158,"state":18,"zip":18,"country":159,"countryCode":160,"cosmosGeoPoint":171,"geoPoint":173,"contacts":174},"Södersjukhuset",{"type":45,"coordinates":172},[163,164],{"lat":164,"lon":163},[175,177],{"name":34,"role":30,"phone":18,"phoneExt":18,"email":176},"emelie.dillenbeck@ki.se",{"name":178,"role":30,"phone":18,"phoneExt":18,"email":179},"Akil Awad, PhD","akil.awad@ki.se",{"type":27,"investigatorFullName":181,"investigatorTitle":182,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Per Nordberg","Senior consultant in cardiology and intensive care, Associate Professor","100518021","prehospital-resuscitation-intranasal-cooling-effectiveness-survival-study-2-100518021",false,"NCT06025123","Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2","Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2 (PRINCESS2)","PRINCESS2","INCLUSION CRITERIA:\n\nPatients ≥18 years that meet all of the following inclusion criteria:\n\n1. Adult out-of-hospital cardiac arrest patients with initial shockable rhythm\n2. Unconsciousness defined as Glasgow Coma Scale \\\u003C 8\n3. Inclusion within 20 minutes from EMS arrival\n\nEXCLUSION CRITERIA:\n\nPatients are not eligible if they meet one or more of the following criteria:\n\n1. Age ≥ 80 years\n2. Obvious non-cardiac causes to cardiac arrest\n3. Obvious already hypothermic\n4. Obvious barrier to placing intra nasal catheters\n5. Have a known Do Not Attempt to Resuscitate (DNAR) order or other limitations in care\n6. Have a known terminal disease\n7. Known or clinically apparent pregnancy","ALL","18 Years","79 Years",{"count":195,"type":196},1022,"ESTIMATED","INTERVENTIONAL",[199],"NA","The aim of this clinical trial is to study the impact of ultra-early transnasal evaporative cooling after cardiac arrest and subsequent hypothermia at hospital, on survival with complete neurologic recovery, compared to currently recommended normothermia. The study population will consist of patients 18-79 years old, with out-of-hospital cardiac arrest with initial shockable rhythm.\n\nThe main research question it aims to answer is whether there is a difference in survival with complete neurologic recovery at 90 days after cardiac arrest between the group of patients that received ultra-early cooling, compared to the group that was treated with normothermia.\n\nParticipants will be randomized to two groups. One group (the intervention group) will receive ultra-early trans-nasal evaporative cooling initiated by EMS personnel at the scene of the cardiac arrest, and subsequent systemic hypothermia for 24 hours at hospital arrival. The other group (the control group), will receive standard of care (advanced cardiac life support and normal body temperature (normothermia)).",[202,203,204],"Out-Of-Hospital Cardiac Arrest","Hypothermia","Ventricular Fibrillation",[206,207,208,209,210,211],"Therapeutic hypothermia","transnasal cooling","neurologic outcome","ultrafast hypothermia","prehospital","ECPR","2025-09-19",{"date":214,"type":215},"2025-09-25","ACTUAL",{"date":217,"type":215},"2024-03-27",{"date":219,"type":196},"2028-05",{"name":5,"class":6},11]