[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652947":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":140,"collaborators":26,"id":142,"slug":143,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":26,"eligibilityCriteria":148,"healthyVolunteers":144,"sex":149,"minAge":150,"maxAge":26,"enrollmentInfo":151,"targetDuration":26,"studyType":154,"phases":155,"briefSummary":157,"conditions":158,"keywords":162,"overallStatus":169,"whyStopped":26,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"fullName":5,"class":6},"Second Affiliated Hospital of Xi'an Jiaotong University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Heated and Humidified Oxygen Group","EXPERIMENTAL","Patients receive oxygen heated to 36-37°C at 5 L\u002Fmin via face mask using a dry-heat blood\u002Ffluid warmer with a flexible heating sleeve. Temperature is measured every 5 minutes to ensure stability within the target range.",[13],"Device: Heated and Humidified Oxygen Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Room-Temperature Oxygen Group","ACTIVE_COMPARATOR","Patients receive room-temperature oxygen at 5 L\u002Fmin via face mask through a bubble humidifier. The same heating device is connected but switched off (sham) to maintain patient blinding. Simulated temperature measurements are recorded as room temperature.",[19],"Device: Room-Temperature Oxygen Therapy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Heated and Humidified Oxygen Therapy","Oxygen heated to 36-37°C using a dry-heat blood\u002Ffluid warmer with a flexible heating sleeve, delivered at 5 L\u002Fmin via face mask. Temperature measured every 5 minutes.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Room-Temperature Oxygen Therapy","Room-temperature oxygen delivered at 5 L\u002Fmin via face mask through a bubble humidifier. Same heating device but switched off (sham), with simulated temperature measurements recorded as room temperature.",[15],[32],{"name":33,"affiliation":5,"role":34},"Lei Ma, MD PhD","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","13519134023","malei0214@xjtu.edu.cn",[41,54,69,80,89,100,114,129],{"facility":42,"status":26,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":26},"Luoyang Central Hospital","Luoyang","Henan","471009","China","CN",{"type":49,"coordinates":50},"Point",[51,52],112.43684,34.67345,{"lat":52,"lon":51},{"facility":55,"status":26,"city":56,"state":57,"zip":58,"country":46,"countryCode":47,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Xi'an Central Hospital","Xi'an","Shaanxi","710003",{"type":49,"coordinates":60},[61,62],108.92861,34.25833,{"lat":62,"lon":61},[65],{"name":66,"role":37,"phone":67,"phoneExt":26,"email":68},"Yuqiang Yan","+86-15389086846","yanyuqianga@126.com",{"facility":70,"status":26,"city":56,"state":57,"zip":71,"country":46,"countryCode":47,"cosmosGeoPoint":72,"geoPoint":74,"contacts":75},"The Second Affiliated Hospital of Xi'an Jiaotong University","710004",{"type":49,"coordinates":73},[61,62],{"lat":62,"lon":61},[76,78,79],{"name":33,"role":37,"phone":77,"phoneExt":26,"email":39},"+86-13519134023",{"name":26,"role":37,"phone":26,"phoneExt":26,"email":39},{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":81,"status":26,"city":56,"state":57,"zip":71,"country":46,"countryCode":47,"cosmosGeoPoint":82,"geoPoint":84,"contacts":85},"Xi'an People's Hospital",{"type":49,"coordinates":83},[61,62],{"lat":62,"lon":61},[86],{"name":87,"role":37,"phone":26,"phoneExt":26,"email":88},"Sheng Hu, +86-13720776109","13720776109@163.com",{"facility":90,"status":26,"city":56,"state":57,"zip":91,"country":46,"countryCode":47,"cosmosGeoPoint":92,"geoPoint":94,"contacts":95},"Shaanxi Provincial People's Hospital","710068",{"type":49,"coordinates":93},[61,62],{"lat":62,"lon":61},[96],{"name":97,"role":37,"phone":98,"phoneExt":26,"email":99},"Hui Wang","+86-15902900973","15902900973@163.com",{"facility":101,"status":26,"city":102,"state":57,"zip":103,"country":46,"countryCode":47,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Shaanxi Nuclear Industry 215 Hospital","Xianyang","712000",{"type":49,"coordinates":105},[106,107],108.70261,34.33778,{"lat":107,"lon":106},[110],{"name":111,"role":37,"phone":112,"phoneExt":26,"email":113},"Liuqin Jiang","+86-15336116822","jlq215hp@163.com",{"facility":115,"status":26,"city":116,"state":117,"zip":118,"country":46,"countryCode":47,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Sichuan Cancer Hospital","Chengdu","Sichuan","610041",{"type":49,"coordinates":120},[121,122],104.06667,30.66667,{"lat":122,"lon":121},[125],{"name":126,"role":37,"phone":127,"phoneExt":26,"email":128},"Jinjun Shu","+86-13550207607","shujinjun@scszlyy.org.cn",{"facility":130,"status":26,"city":116,"state":117,"zip":131,"country":46,"countryCode":47,"cosmosGeoPoint":132,"geoPoint":134,"contacts":135},"General Hospital of Western Theater Command, PLA","610083",{"type":49,"coordinates":133},[121,122],{"lat":122,"lon":121},[136],{"name":137,"role":37,"phone":138,"phoneExt":26,"email":139},"Yu Liang","+86-13183826872","81271281@qq.com",{"type":141,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100652947","heated-humidified-oxygen-in-pacu-patients-100652947",false,"NCT07778420","Heated Humidified Oxygen in PACU Patients","Effect of Heated and Humidified Oxygen Therapy on the Incidence of Early Hypoxemia in Adult Patients During General Anesthesia Recovery in the Post-Anesthesia Care Unit: A Prospective, Multicenter, Randomized, Superiority Trial","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Undergoing elective or emergency surgery under general anesthesia with endotracheal intubation\n3. Ramsay Sedation Score of 2-4 at 1 minute after extubation\n4. ASA physical status class I-III\n5. Expected PACU stay ≥ 30 minutes\n6. Patient or legally authorized representative provides written informed consent\n\nExclusion Criteria:\n\n1. Pre-existing hypoxemia (SpO₂ \\\u003C 90% on room air)\n2. Pre-existing diagnosis of severe chronic obstructive pulmonary disease (GOLD grade 3-4), interstitial lung disease, or uncontrolled asthma\n3. Severe cardiovascular disease (NYHA class III-IV heart failure, unstable angina)\n4. Neuromuscular disease affecting respiratory function\n5. Maxillofacial surgery, severe spinal deformity, or other contraindications to face mask oxygen therapy or positioning\n6. Use of cardiopulmonary bypass during surgery or planned postoperative ICU admission with endotracheal tube in place\n7. Known intolerance to heated gas","ALL","18 Years",{"count":152,"type":153},2000,"ESTIMATED","INTERVENTIONAL",[156],"NA","This study aims to determine whether heated and humidified oxygen therapy, compared with conventional room-temperature oxygen therapy, reduces the incidence of early hypoxemia in adult patients recovering from general anesthesia in the Post-Anesthesia Care Unit (PACU).\n\nHypoxemia is a common and potentially life-threatening complication during PACU recovery, resulting from residual anesthetics, decreased upper airway muscle tone, atelectasis, and suppression of hypoxic pulmonary vasoconstriction (HPV). Heated and humidified oxygen may offer benefits by preserving optimal HPV function, protecting airway mucosa, and reducing respiratory resistance.\n\nThis is a prospective, multicenter, randomized, superiority trial with a parallel-group design. A total of 2,000 adult patients (ASA class I-III) undergoing general anesthesia will be enrolled and randomly assigned in a 1:1 ratio to receive either heated and humidified oxygen (37°C, 5 L\u002Fmin via face mask) or room-temperature oxygen (room temperature, 5 L\u002Fmin via face mask).\n\nThe primary outcome is the incidence of hypoxemia, defined as SpO₂ ≤ 90% lasting ≥ 5 seconds, within 10 minutes after initiation of the intervention. Secondary outcomes include severe hypoxemia (SpO₂ ≤ 85%), requirement for airway interventions, lowest SpO₂ value, PACU length of stay, postoperative shivering, and agitation. Safety outcomes include nasal discomfort, epistaxis, and device-related adverse events.",[159,160,161],"Hypoxemia","Postoperative Complications","Anesthesia Recovery Period",[163,164,165,166,167,168],"Heated and Humidified Oxygen","General Anesthesia","PACU","Randomized Controlled Trial","Oxygen Therapy","Post-Anesthesia Care Unit","NOT_YET_RECRUITING","2026-08-18",{"date":172,"type":173},"2026-08-21","ACTUAL",{"date":175,"type":153},"2026-09-01",{"date":177,"type":153},"2027-12-30",{"name":5,"class":6},8]