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NCT Number: NCT07618416

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, China, 100730

Location status: Recruiting

Location contact

Quexuan Cui

CONTACT

[email protected]

13520921711

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence of Post-Induction Hypotension (PIH)

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

    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.

Secondary outcomes

  1. 1. Early Intraoperative Hypotension Rate

    Time frame: From surgical incision to the end of the operation.

    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.

  2. Postoperative Complication

    Time frame: Up to 30 days post-surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Quexuan Cui, Dr.

CONTACT

[email protected]

+8613520921711

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Development of a Baroreflex Sensitivity-Based Multifactorial Machine Learning Model for Predicting Post-Induction Hypotension in Elderly Patients

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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