[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636686":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":17,"locations":10,"responsibleParty":26,"collaborators":10,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":34,"acronym":10,"eligibilityCriteria":35,"healthyVolunteers":31,"sex":36,"minAge":37,"maxAge":10,"enrollmentInfo":38,"targetDuration":41,"studyType":42,"phases":10,"briefSummary":43,"conditions":44,"keywords":10,"overallStatus":46,"whyStopped":10,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":10},{"fullName":5,"class":6},"China-Japan Friendship Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Frailty-Hypoxemia ERCP Cohort",null,"This study employs a dual-cohort design consisting of a retrospective cohort and a prospective cohort. The retrospective cohort includes 313 patients aged 65 years and older who underwent elective ERCP under anesthesia sedation with complete electronic health record data. The prospective cohort will enroll 388 consecutive eligible patients aged 65 years and older undergoing elective ERCP under anesthesia sedation, with prospective frailty assessment and standardized perioperative data collection. This cohort will be used to validate the independent association between frailty and hypoxemia, refine the prediction model, and assess its performance in terms of discrimination, calibration, and clinical utility. Frailty will be assessed primarily using the Frailty Index (FI), with supplementary screening using other validated scales. All patients will be managed according to routine clinical practice without additional investigation.",[13],{"name":14,"affiliation":15,"role":16},"Lifang Wang, M.D.","China-Japan Friendship Hospital, Department of Anesthesiology","PRINCIPAL_INVESTIGATOR",[18,22],{"name":14,"role":19,"phone":20,"phoneExt":10,"email":21},"CONTACT","8601084205882","lilythewolf@sina.com",{"name":23,"role":19,"phone":24,"phoneExt":10,"email":25},"Dongni Zhang, M.D.","86013520376775","dongnizhang1219@gmail.com",{"type":16,"investigatorFullName":27,"investigatorTitle":28,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Li Fang Wang","Principal Investigator","100636686","frailty-and-intraoperative-hypoxemia-risk-in-elderly-ercp-patients-100636686",false,"NCT07568912","Frailty and Intraoperative Hypoxemia Risk in Elderly ERCP Patients","The Predictive Value of Frailty for Intraoperative Hypoxemia in Elderly Patients Undergoing ERCP: A Two-Directional Cohort Study and Predictive Model Construction","Inclusion Criteria:\n\n1. Age 65 years or older\n2. Elective endoscopic retrograde cholangiopancreatography (ERCP) under anesthesia sedation\n3. American Society of Anesthesiologists (ASA) physical status II-IV\n4. Expected procedure duration less than 60 minutes\n5. Available and complete intraoperative pulse oximetry (SpO₂) monitoring data\n\nExclusion Criteria:\n\n1. Emergency ERCP\n2. Severe anemia (hemoglobin \\\u003C 60 g\u002FL) or conditions interfering with accurate 3. SpO₂ measurement\n\n4\\. Pre-existing severe respiratory insufficiency requiring long-term oxygen therapy 5. Unstable hemodynamics requiring continuous vasopressor infusion Impaired consciousness, delirium, or cognitive dysfunction that prevents reliable frailty assessment","ALL","65 Years",{"count":39,"type":40},701,"ESTIMATED","3 Months","OBSERVATIONAL","Intraoperative hypoxemia is a common and serious complication during monitored anesthesia care for elective endoscopic retrograde cholangiopancreatography (ERCP), especially in older adults. Frail patients have reduced physiologic reserve and are at increased risk of life-threatening events including unplanned intubation, hemodynamic collapse, and hypoxic brain injury. However, the independent relationship between frailty and intraoperative hypoxemia during sedated ERCP remains poorly defined, and no validated risk prediction model exists for this high-risk population. This single-center, dual-cohort study will be conducted at China-Japan Friendship Hospital to evaluate whether preoperative frailty can predict intraoperative hypoxemia in patients aged 65 years and older undergoing elective ERCP. Frailty will be assessed primarily using the Frailty Index (FI), with secondary screening by the Modified Frailty Index-11 (mFI-11), Edmonton Frail Scale (EFS), Clinical Frailty Scale (CFS), FRAIL scale, and Fried phenotype. The primary outcome is intraoperative hypoxemia, defined as SpO₂ \\\u003C 90% for 5 seconds or longer. In the retrospective phase (n = 313), investigators will identify risk factors and develop a preliminary prediction model. In the prospective phase (n = 388), the model will be validated, refined, and internally tested for discrimination, calibration, and clinical utility. This study aims to establish frailty as a reliable preoperative risk marker and provide a clinically practical prediction tool to support risk stratification, personalized sedation strategies, and perioperative safety in elderly patients undergoing ERCP.",[45],"Hypoxemia","NOT_YET_RECRUITING","2026-05-01",{"date":49,"type":50},"2026-05-06","ACTUAL",{"date":52,"type":40},"2026-06-01",{"date":54,"type":40},"2028-12-31",{"name":5,"class":6}]