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A Study on the Prediction of Vital Signs During Anesthesia Using Multisource Intraoperative Data and Individualized PK-PD Models

A Study on the Prediction of Vital Signs During Anesthesia Using Multisource Intraoperative Data and Individualized PK-PD Models

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600125655
Enrollment
Unknown
Registered
2026-05-29
Start date
2026-05-30
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Changes in vital signs under general anesthesia

Interventions

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: This study presents the development and external validation of vital signs prediction models, constructed using the publicly available Korean VitalDB database and externally validated at our center. Model Development Cohort Study subjects for model development were derived from the VitalDB database. The inclusion criteria were as follows: (a) underwent general anesthesia with mechanical ventilation; (b) had relatively complete intraoperative monitoring data for bispectral index (BIS), heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP); and (c) had infusion records for major anesthetic drugs, including intravenous anesthetics and opioids. External Validation Cohort Study subjects for external validation were obtained from West China Hospital, Sichuan University. The inclusion criteria were as follows: (a) patients who underwent elective surgery under general anesthesia with mechanical ventilation; and (b) relatively complete intraoperative continuous monitoring data, enabling acquisition of major vital signs including BIS, HR, SBP, DBP and MAP, along with records of major anesthetic drug administration and related perioperative clinical data.

Exclusion criteria

Exclusion criteria: The exclusion criteria for the model development cohort derived from the VitalDB database were as follows: (a) severe missingness in key monitoring tracks, precluding the formation of complete input sequences; (b) prolonged interruptions in primary target variables, rendering them unsuitable for label construction in future time-point prediction tasks; and (c) obviously abnormal raw data, such as monitoring values persistently exceeding physiologically plausible ranges, disordered timestamps, or logically inconsistent variable recordings. The exclusion criteria for the external validation cohort obtained from West China Hospital, Sichuan University were as follows: (a) significant interference in intraoperative key vital signs signals, resulting in distorted monitoring values or inability to continuously reflect physiological status; (b) severe missingness in primary input variables, precluding the construction of unified time series; and (c) incomplete or misaligned temporal information across different data modalities.

Design outcomes

Primary

MeasureTime frame
Model predicts future 3-minute BIS performance;

Secondary

MeasureTime frame
Model predicts future 3-minute HR performance;Model predicts future 3-minute HR performance;Accuracy of the model in predicting adverse events related to vital signs;Ability to predict adverse events in vital signs;

Countries

China

Contacts

Public ContactWensheng Zhang

West China Hospital of Sichuan University

zhang_ws@scu.edu.cn+86 189 8060 1564

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026