{"type":"trials","record":{"id":34853,"source_id":"clinicaltrials-gov","external_id":"NCT07568912","title":"Frailty and Intraoperative Hypoxemia Risk in Elderly ERCP Patients","brief_summary":"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 \\< 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.","overall_status":"Not Yet Recruiting","phases":[],"study_type":"OBSERVATIONAL","sponsor":"China-Japan Friendship Hospital","enrollment":701,"countries":[],"start_date":"2026-06-01","completion_date":"2028-12-31","last_update_date":"2026-05-06","source_url":"https://clinicaltrials.gov/study/NCT07568912","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Not Yet Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:20:20.087268+00:00","last_seen_at":"2026-09-25T06:10:07.378+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"65 Years","comparator":null,"organization":"China-Japan Friendship Hospital","interventions":[],"registry_source":"ClinicalTrials.gov","outcome_measures":["Intraoperative hypoxemia — Intraoperatively","Severe intraoperative hypoxemia — Intraoperatively","Postoperative hypoxemia — Within 2 hours after completion of ERCP","Intraoperative hemodynamic instability — Intraoperatively","Serious anesthesia-related adverse events — up to 1 month","Serious procedure-related adverse events — up to 1 month","Intraoperative respiratory depression and apnea — Intraoperatively"],"design_description":null,"source_has_results":false},"controlled_terms":["Hypoxemia"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: frailty.","quality_checked_at":"2026-09-25T06:10:20.034853+00:00","duplicate_cluster_key":"id:nct07568912","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-06-01 to 2028-12-31","comparator":null,"confidence":"structured-source","population":"ALL · 65 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:10:07.437Z","intervention":[],"participants":701,"study_design":"OBSERVATIONAL","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Intraoperative hypoxemia — Intraoperatively","Severe intraoperative hypoxemia — Intraoperatively","Postoperative hypoxemia — Within 2 hours after completion of ERCP","Intraoperative hemodynamic instability — Intraoperatively","Serious anesthesia-related adverse events — up to 1 month","Serious procedure-related adverse events — up to 1 month","Intraoperative respiratory depression and apnea — Intraoperatively"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"frailty","is_published":true,"match_reasons":["Title contains controlled term: frailty.","Abstract contains controlled term: frailty, frailty index.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as OBSERVATIONAL."],"matched_fields":["title","abstract","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Frailty","slug":"frailty"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/34853","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}