Frailty and Intraoperative Hypoxemia Risk in Elderly ERCP Patients

NCT07568912 | Not Yet Recruiting

• 1 other identifier: ZRYH-Hypoxemia-Frailty-2026
• Study Type: observational
• Target: 701
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypoxemia

Outcome Measures

Primary Outcomes (1)

• Intraoperative hypoxemia

  Intraoperative hypoxemia defined as pulse oxygen saturation (SpO₂) \< 90% lasting 5 seconds or longer during the procedure.

  Intraoperatively

Secondary Outcomes (6)

• 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

Study Arms (1)

Frailty-Hypoxemia ERCP Cohort

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This observational cohort study will enroll elderly patients aged 65 years and older who are scheduled for elective endoscopic retrograde cholangiopancreatography (ERCP) under anesthesia sedation at China-Japan Friendship Hospital. The study population consists of two sequential cohorts: a retrospective cohort of 313 patients with complete electronic health record data and a prospective cohort of 388 patients to be recruited prospectively. Eligible participants include those with American Society of Anesthesiologists (ASA) physical status II-IV and an expected procedure duration of less than 60 minutes, with adequate intraoperative pulse oximetry monitoring.

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

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lifang Wang, M.D.

  China-Japan Friendship Hospital, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lifang Wang, M.D.

CONTACT

8601084205882; lilythewolf@sina.com

Dongni Zhang, M.D.

CONTACT

86013520376775; dongnizhang1219@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Individual participant data (IPD) and supporting information will be made available within 1 month after the publication of study results, with access maintained for 5 years after study completion.
• Access Criteria: Eligible researchers must submit a research application specifying the purpose of data use and research plan, which will be reviewed and approved by the Institutional Review Board of China-Japan Friendship Hospital.A data use agreement must be signed, committing to use the data solely for scientific research, protect participants' privacy, refrain from unauthorized data transfer, and cite this study in published outcomes.De-identified data will be accessible through the hospital's designated secure data repository.