[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607290":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":34,"centralContacts":43,"locations":53,"responsibleParty":86,"collaborators":88,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":29,"enrollmentInfo":102,"targetDuration":29,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":115,"overallStatus":56,"whyStopped":29,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Monash University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Liberal inspired oxygen","ACTIVE_COMPARATOR","FiO2 0.8; i.e. 80%",[13],"Drug: Liberal inspired oxygen",{"label":15,"type":10,"description":16,"interventionNames":17},"Conservative inspired oxygen","FiO2 ≤0.3 \\[30%\\]",[18],"Drug: Conservative inspired oxygen",{"label":20,"type":10,"description":21,"interventionNames":22},"Intermediate inspired oxygen","FiO2 0.5 \\[50%\\]",[23],"Drug: Intermediate inspired oxygen",[25,30,32],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","The concentration of Oxygen will differ according to the randomisation",[9],null,{"type":26,"name":15,"description":15,"armGroupLabels":31,"otherNames":29},[15],{"type":26,"name":20,"description":20,"armGroupLabels":33,"otherNames":29},[20],[35,38,40],{"name":36,"affiliation":5,"role":37},"Paul s Myles, DSc","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":5,"role":37},"Trisha Peel, PhD",{"name":41,"affiliation":42,"role":37},"Daniel Frei, PhD","Wellington Reginal Hospital",[44,50],{"name":45,"role":46,"phone":47,"phoneExt":48,"email":49},"Paul S Myles, DSc","CONTACT","+6190762000","63176","p.myles@alfred.org.au",{"name":39,"role":46,"phone":51,"phoneExt":29,"email":52},"+61 3 9076 5436","trisha.peel@monash.edu",[54,75],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"The Alfred","RECRUITING","Melbourne","Victoria","3004","Australia","AU",{"type":63,"coordinates":64},"Point",[65,66],144.96332,-37.814,{"lat":66,"lon":65},[69,71],{"name":45,"role":46,"phone":70,"phoneExt":48,"email":49},"61390762000",{"name":72,"role":46,"phone":73,"phoneExt":29,"email":74},"Sophie Wallace K, PhD","+61390762651","s.wallace@alfred.org.au",{"facility":76,"status":56,"city":77,"state":78,"zip":79,"country":80,"countryCode":78,"cosmosGeoPoint":81,"geoPoint":85,"contacts":29},"Wellington Hospital","Wellington","NZ","6012","New Zealand",{"type":63,"coordinates":82},[83,84],174.77557,-41.28664,{"lat":84,"lon":83},{"type":87,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[89,90],{"name":55,"class":6},{"name":76,"class":91},"OTHER_GOV","100607290","phase-4-perioperative-medicine-platform-trial-100607290",false,"NCT07186634","PeRiOperative Medicine Platform Trial","Domain-Specific Appendix: OXYGEN","PROMPT","PROMPT - Inclusion Criteria:\n\n* Adult patient (≥18 years of age at time of admission)\n* Scheduled to undergo a surgical procedure involving a skin incision, with an expected duration of at least 2 hours, and a planned overnight hospital stay of at least 1 night (including, but not limited to, cardiac surgery, orthopedic surgery, obstetric, or gynecological surgery).\n\nPROMPT - Exclusion Criteria:\n\n* ASA physical status 5 (moribund, not expected to survive with or without an operation)\n* Inability to provide informed consent\n* Previous participation in PROMPT within the prior 30 days.\n\nDSA 02 - PROMPT - Exclusion Criteria:\n\n* ASA physical status 1 or 2\n* Undergoing cardiac surgery\n* Undergoing thoracic surgery if one-lung ventilation is required\n* Currently suspected or proven infection\n* Advanced lung disease requiring home oxygen therapy\n* Previous bleomycin therapy\n* Known or suspected pregnancy","ALL","18 Years",{"count":103,"type":104},7800,"ESTIMATED","INTERVENTIONAL",[107],"PHASE4","Our specific aims are to investigate whether conservative (≤30%), intermediate (50%), or liberal (80%) inspired oxygen during and immediately after surgery: Aim 1: Reduces surgical site infections (SSIs or \"wound infections\") and other healthcare-associated infections (pneumonia and sepsis). Aim 2: Reduces a pooled composite of serious postoperative complications, leading to a faster and more complete recovery after surgery, and thus increases \"days alive and at home up to 30 days after surgery\" (DAH30). Primary hypothesis: Liberal (80%) oxygen concentration delivered with anesthesia in patients undergoing major surgery reduces the incidence of SSIs after surgery compared to conservative (≤30%) or intermediate (50%) oxygen concentration. Secondary hypothesis: Hyperoxia (50-80%) delivered with anesthesia in patients undergoing major surgery increases the incidence of pulmonary and other complications after surgery compared to conservative (≤30%) oxygen concentration, resulting in fewer Days At Home (DAH). PROMPT enrolls patients undergoing elective or semi-elective surgery.",[110,111,112,113,114],"Surgical Site Infection After Major Surgery","Anaesthesia","Major Complications","Quality of Recovery (QoR-15)","Quality of Life",[116,117],"Anaesthesiology, complications, oxygen, surgery","platform trial","2026-04-14",{"date":120,"type":121},"2026-04-17","ACTUAL",{"date":123,"type":121},"2026-04-06",{"date":125,"type":104},"2035-12",{"name":5,"class":6},2]