- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07618416
Machine Learning Model Based on Baroreflex Sensitivity for Predicting Post-Induction Hypotension in Elderly Patients
Development of a Baroreflex Sensitivity-Based Multifactorial Machine Learning Model for Predicting Post-Induction Hypotension in Elderly Patients
Study Overview
Status
Conditions
Detailed Description
Aging significantly alters cardiovascular autonomic function, characterized by elevated sympathetic and decreased parasympathetic tone, rendering elderly patients highly vulnerable to post-induction hypotension (PIH). While existing machine learning models heavily rely on static data (e.g., baseline blood pressure, demographics, medication history), they lack real-time dynamic regulatory inputs, limiting their predictive performance in individualized care.
This single-center, prospective cohort study aims to bridge this gap by introducing preoperative BRS parameters-calculated via the continuous non-invasive arterial pressure (CNAP) method-into machine learning frameworks. A total of 500 patients aged over 65 years scheduled for elective non-cardiac surgery will be enrolled. Preoperative data, including autonomic indices, frailty assessments, and static clinical factors, will be mapped alongside intraoperative events and 30-day postoperative complications. Multiple machine learning algorithms (Logistic Regression, Random Forest, GBDT, XGBoost, LightGBM, and LSTM) will be leveraged and optimized using cross-validation to construct a robust clinical decision-support pipeline.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Quexuan Cui, Dr.
- Phone Number: +8613520921711
- Email: Cuiqx_garfield@126.com
Study Locations
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China
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Beijing, China, China, 100730
- Recruiting
- Peking Union Medical College Hospital
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Contact:
- Quexuan Cui
- Phone Number: 13520921711
- Email: Cuiqx_garfield@126.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aged over 65 years;
- Scheduled for elective non-cardiac surgery;
- American Society of Anesthesiologists (ASA) physical status classification I-III;
- Planned for general anesthesia with endotracheal intubation;
- Patient and legal guardians are capable of understanding the study protocol and willing to provide written informed consent.
Exclusion Criteria:
- Severe peripheral vascular diseases;
- Secondary hypertension;
- Presence of physical tremors (e.g., Parkinson's disease) preventing stable recording;
- Inability to accurately measure upper limb blood pressure;
- Pre-existing cardiac arrhythmias (e.g., atrial fibrillation) that render BRS;
- Psychiatric disorders or cognitive impairments hindering basic cooperation.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Elderly Surgical Patients
Patients aged over 65 years who are undergoing elective non-cardiac surgery under general anesthesia with endotracheal intubation.
All patients will receive continuous non-invasive hemodynamic monitoring prior to anesthesia induction to calculate baseline BRS parameters.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of Post-Induction Hypotension (PIH)
Time Frame: From immediately after anesthesia induction up to 20 minutes post-induction or before surgical incision.
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Defined as a systolic blood pressure (SBP) <90 mmHg , a mean arterial pressure (MAP) <65 mmHg, or a decrease in MAP exceeding 30% from baseline measurements.
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From immediately after anesthesia induction up to 20 minutes post-induction or before surgical incision.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1. Early Intraoperative Hypotension Rate
Time Frame: From surgical incision to the end of the operation.
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Defined as a systolic blood pressure (SBP) <90 mmHg , a mean arterial pressure (MAP) <65 mmHg, or a decrease in MAP exceeding 30% from baseline measurements.
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From surgical incision to the end of the operation.
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Postoperative Complication
Time Frame: Up to 30 days post-surgery
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Up to 30 days post-surgery
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025-PUMCH-A-119 (Other Grant/Funding Number: Peking Union Medical College Hospital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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