Machine Learning Model Based on Baroreflex Sensitivity for Predicting Post-Induction Hypotension in Elderly Patients

NCT07618416 | Recruiting DMC

• 1 other identifier: 2025-PUMCH-A-119
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop a high-performance machine learning model combining dynamic baroreflex sensitivity (BRS) metrics and multi-dimensional static clinical features to predict the risk of post-induction hypotension (PIH) in elderly patients undergoing elective non-cardiac surgery under general anesthesia.

Conditions

Post Induction Hypotension

Keywords

post-induction hypotension; elderly patient; baroreflex sensitivity; machine learning

Outcome Measures

Primary Outcomes (1)

• Incidence of Post-Induction Hypotension (PIH)

  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.

  From immediately after anesthesia induction up to 20 minutes post-induction or before surgical incision.

Secondary Outcomes (2)

• 1. Early Intraoperative Hypotension Rate

  From surgical incision to the end of the operation.

• Postoperative Complication

  Up to 30 days post-surgery

Study Arms (1)

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.

Eligibility Criteria

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

Study Population

Patients scheduled for elective operations

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China, 100730, China

RECRUITING

Central Study Contacts

Quexuan Cui, Dr.

CONTACT

+8613520921711; Cuiqx_garfield@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 1, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

CN (1)