HypoxemiaNCT07568912
Frailty and Intraoperative Hypoxemia Risk in Elderly ERCP Patients
An observational study of Hypoxemia, run by China-Japan Friendship Hospital.
Trial summary
Intraoperative hypoxemia is a common and serious complication during monitored anesthesia care for elective endoscopic retrograde cholangiopancreatography (ERCP), especially in older adults. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypoxemia
- How many people
- 701 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 Dec 2028
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- Emergency ERCP
- Severe anemia (hemoglobin < 60 g/L) or conditions interfering with accurate 3. SpO₂ measurement
- 4. 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Predictive Value of Frailty for Intraoperative Hypoxemia in Elderly Patients Undergoing ERCP: A Two-Directional Cohort Study and Predictive Model Construction
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.
Read the detailed description
This dual-cohort study investigates the predictive value of preoperative frailty for intraoperative hypoxemia in patients aged 65 years and older undergoing elective endoscopic retrograde cholangiopancreatography (ERCP) under monitored anesthesia care at China-Japan Friendship Hospital, with a total target enrollment of 701 patients (313 retrospective and 388 prospective). Intraoperative hypoxemia, defined as pulse oxygen saturation (SpO₂) < 90% for 5 seconds or longer from anesthesia induction to procedure completion, serves as the primary outcome, while secondary outcomes include severe hypoxemia, postoperative hypoxemia, time to oxygen discontinuation, hemodynamic instability, anesthesia- and procedure-related adverse events, respiratory depression, and apnea. Frailty will be assessed primarily using the Frailty Index (FI) as the core instrument, with additional secondary screening performed using the Modified Frailty Index-11 (mFI-11), Edmonton Frail Scale (EFS), Clinical Frailty Scale (CFS), FRAIL questionnaire, and Fried frailty phenotype. Eligible patients are aged 65 years or older with ASA class II-IV status, scheduled for elective ERCP with a planned procedure duration of less than 60 minutes and complete intraoperative SpO₂ monitoring data; those requiring emergency surgery, severe anemia, pre-existing severe respiratory or hemodynamic instability, or impaired consciousness will be excluded. The retrospective phase will use existing electronic health records to identify risk factors and construct a preliminary prediction model, with propensity score matching, univariate and multivariable logistic regression, bootstrap internal validation, and random forest for feature importance ranking. The prospective phase will prospectively collect standardized data, validate the association between frailty and hypoxemia using adjusted logistic regression, refine the prediction model, compare the performance of different frailty scales using Delong's test, and evaluate machine learning models with SHapley Additive exPlanations (SHAP) values for interpretability. The final model will be tested in an internal validation cohort for discriminative ability, calibration, and clinical utility. All statistical analyses will be performed using R and SPSS software at a two-sided significance level of α = 0.05, with multiple imputation for missing data and Holm-Bonferroni correction for multiple comparisons.
- Conditions
- Hypoxemia
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative hypoxemia
Intraoperative hypoxemia defined as pulse oxygen saturation (SpO₂) < 90% lasting 5 seconds or longer during the procedure.
Measured: Intraoperatively
Secondary outcomes (6)
Severe intraoperative hypoxemia
Severe hypoxemia defined as SpO₂ < 90% for more than 1 minute, or SpO₂ < 75%.
Measured: Intraoperatively
Postoperative hypoxemia
Hypoxemia on admission to the ward, defined as SpO₂ < 90% on room air.
Measured: Within 2 hours after completion of ERCP
Intraoperative hemodynamic instability
Clinically significant hypotension, hypertension, or arrhythmia requiring intervention.
Measured: Intraoperatively
Serious anesthesia-related adverse events
Aspiration, circulatory instability, unplanned endotracheal intubation, hypoxic encephalopathy, or death.
Measured: up to 1 month
Serious procedure-related adverse events
Post-ERCP pancreatitis, bleeding, perforation, or cholangitis.
Measured: up to 1 month
Intraoperative respiratory depression and apnea
Respiratory rate < 8 breaths per minute or apnea (respiratory pause ≥ 15 seconds).
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 701 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Fang Wang, China-Japan Friendship Hospital
- Investigators
- Lifang Wang, M.D., Principal investigator, China-Japan Friendship Hospital, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568912
- Sponsor's protocol ID
- ZRYH-Hypoxemia-Frailty-2026
- Status last verified
- May 2026
- First submitted
- 23 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be shared with qualified researchers upon reasonable request, following publication of the study results. Shared data will include de-identified clinical information (baseline characteristics, intraoperative parameters, postoperative outcomes) and biomarker data, excluding direct identifiers to protect participant privacy. Data access will require approval from the institutional review board of China-Japan Friendship Hospital and a signed data use agreement specifying the purpose of use and confidentiality obligations. The data will be shared via a secure research data repository for up to 5 years after study completion
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of Frailty for Intraoperative Hypoxemia in Elderly Patients Undergoing ERCP: A Two-Directional Cohort Study and Predictive Model Construction
- ClinicalTrials.gov ID
- NCT07568912
- Acronym / sponsor ID
- ZRYH-Hypoxemia-Frailty-2026
- Conditions
- Hypoxemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 701 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This dual-cohort study investigates the predictive value of preoperative frailty for intraoperative hypoxemia in patients aged 65 years and older undergoing elective endoscopic retrograde cholangiopancreatography (ERCP) under monitored anesthesia care at China-Japan Friendship Hospital, with a total target enrollment of 701 patients (313 retrospective and 388 prospective). Intraoperative hypoxemia, defined as pulse oxygen saturation (SpO₂) < 90% for 5 seconds or longer from anesthesia induction to procedure completion, serves as the primary outcome, while secondary outcomes include severe hypoxemia, postoperative hypoxemia, time to oxygen discontinuation, hemodynamic instability, anesthesia- and procedure-related adverse events, respiratory depression, and apnea. Frailty will be assessed primarily using the Frailty Index (FI) as the core instrument, with additional secondary screening performed using the Modified Frailty Index-11 (mFI-11), Edmonton Frail Scale (EFS), Clinical Frailty Scale (CFS), FRAIL questionnaire, and Fried frailty phenotype. Eligible patients are aged 65 years or older with ASA class II-IV status, scheduled for elective ERCP with a planned procedure duration of less than 60 minutes and complete intraoperative SpO₂ monitoring data; those requiring emergency surgery, severe anemia, pre-existing severe respiratory or hemodynamic instability, or impaired consciousness will be excluded. The retrospective phase will use existing electronic health records to identify risk factors and construct a preliminary prediction model, with propensity score matching, univariate and multivariable logistic regression, bootstrap internal validation, and random forest for feature importance ranking. The prospective phase will prospectively collect standardized data, validate the association between frailty and hypoxemia using adjusted logistic regression, refine the prediction model, compare the performance of different frailty scales using Delong's test, and evaluate machine learning models with SHapley Additive exPlanations (SHAP) values for interpretability. The final model will be tested in an internal validation cohort for discriminative ability, calibration, and clinical utility. All statistical analyses will be performed using R and SPSS software at a two-sided significance level of α = 0.05, with multiple imputation for missing data and Holm-Bonferroni correction for multiple comparisons.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Emergency ERCP
- Severe anemia (hemoglobin < 60 g/L) or conditions interfering with accurate 3. SpO₂ measurement
- 4. 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intraoperative hypoxemia
Time frame: Intraoperatively
Intraoperative hypoxemia defined as pulse oxygen saturation (SpO₂) < 90% lasting 5 seconds or longer during the procedure.
6 secondary outcomes
Severe intraoperative hypoxemia
Time frame: Intraoperatively
Postoperative hypoxemia
Time frame: Within 2 hours after completion of ERCP
Intraoperative hemodynamic instability
Time frame: Intraoperatively
Serious anesthesia-related adverse events
Time frame: up to 1 month
Serious procedure-related adverse events
Time frame: up to 1 month
Intraoperative respiratory depression and apnea
Time frame: Intraoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be shared with qualified researchers upon reasonable request, following publication of the study results. Shared data will include de-identified clinical information (baseline characteristics, intraoperative parameters, postoperative outcomes) and biomarker data, excluding direct identifiers to protect participant privacy. Data access will require approval from the institutional review board of China-Japan Friendship Hospital and a signed data use agreement specifying the purpose of use and confidentiality obligations. The data will be shared via a secure research data repository for up to 5 years after study completion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lifang Wang, M.D. principal investigator
China-Japan Friendship Hospital, Department of Anesthesiology
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxemia, run by China-Japan Friendship Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lifang Wang, M.D. (8601084205882, lilythewolf@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative hypoxemia (time frame: Intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.