Frailty and Intraoperative Hypoxemia Risk in Elderly ERCP Patients

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Conditions studied: Hypoxemia

In brief

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.

Key facts

Study ID: NCT07568912
Run by: China-Japan Friendship Hospital
People needed: 701
Starts: 2026-06-01
Expected to finish: 2028-12-31
Last updated by the study team: 2026-05-06

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age 65 years or older
Elective endoscopic retrograde cholangiopancreatography (ERCP) under anesthesia sedation
American Society of Anesthesiologists (ASA) physical status II-IV
Expected procedure duration less than 60 minutes
Available and complete intraoperative pulse oximetry (SpO₂) monitoring data

You may not qualify if…

Emergency ERCP
Severe anemia (hemoglobin < 60 g/L) or conditions interfering with accurate 3. SpO₂ measurement
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

Full record on ClinicalTrials.gov

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