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Can frailty predict low oxygen during procedure sedation in older adults?

Opening soon · China-Japan Friendship Hospital

What this means

This study is a plan to test whether frail older patients have more low-oxygen episodes during ERCP sedation. It has not started recruiting, so no results exist yet.

Plain-English summary written by an AI model from the registry listing.

Status
Opening soon
Who can join
Ages 65 and over · 701 patients aged 65 and older planned for ERCP, in one hospital in China (313 retrospective, 388 prospective)
Where
Not listed

Contacts and how to join ↗

The science

Registered title
Frailty and Intraoperative Hypoxemia Risk in Elderly ERCP Patients
Phase
Not applicable
Study type
observational
Conditions
Hypoxemia
Sponsor
China-Japan Friendship Hospital
Ages
65 Years to no maximum
Dates
First posted May 6, 2026 · updated May 6, 2026

Registry 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.

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