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Recruiting NCT07618416

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

Observational Post Induction Hypotension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Post Induction Hypotension. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Primary outcome measures

  • Incidence of Post-Induction Hypotension (PIH) [Time frame: From immediately after anesthesia induction up to 20 minutes post-induction or before surgical incision.]
Secondary outcome measures (2)
  • 1. Early Intraoperative Hypotension Rate [Time frame: From surgical incision to the end of the operation.]
  • Postoperative Complication [Time frame: Up to 30 days post-surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Peking Union Medical College Hospital — Beijing

Identifiers

NCT: NCT07618416 · 2025-PUMCH-A-119 · 2025-PUMCH-A-119

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗