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Starting soon Observational

Deep Learning Model for Predicting a Peripheral Venous Waveform-based Pulse Pressure Variation

NCT06734650 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2024-12-28
Last updated
2024-12-16

Condition(s) studied

Peripheral VeinArterial Wave ReflectionsPulse Pressure VariationStroke Volume VariationDeep Learning Model

Investigational drug(s) / intervention(s)

peripheral waveform collection

peripheral waveform collection: The peripheral venous pressure waveform is collected by connecting a pressure transducer that is currently in use to the placed central venous line. In addition, the pulse pressure variation or stroke volume variation value that can be obtained from the arterial catheter. This extracts the medical records and bio-signal information of the subjects registered through the previously approved 'Establishment of a Bio-signal and Clinical Information Registry for the Development of Patient Monitoring Algorithm' study (B-2202-738-401).

Study summary

Pulse pressure variation is a monitoring index that indicates the response to fluid therapy in patients receiving mechanical ventilation, and is used as a reference for patients with unstable hemodynamic conditions. However, it is invasive because it requires arterial puncture to collect it. In a previous study by the investigators, the investigators developed and verified an artificial intelligence model that predicts stroke volume variation, in real time using only the central venous pressure waveform. However, since a large vein such as the jugular vein must be punctured to collect the central venous pressure waveform, it is still invasive, and its clinical utility is low. Therefore, in this study, the investigators collected waveforms from peripheral veins that are less invasive and can be a wide range of applications because all surgical patients have them. The investigators aimed to develop and verify an artificial intelligence model that predicts pulse pressure variation obtained from peripheral venous waveforms .

Eligibility

Sex
ALL
Min age
19 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Patients who voluntarily agreed and signed the written informed consent form before participating in this study * Adult aged 19 years or older * American Society of Anesthesiologists physical class (ASA) 1-3 * Patients scheduled for elective hepatectomy under general anesthesia * Patients who require arterial pressure monitoring and additional peripheral venous access for routine anesthesia preparation * Non-smokers with normal pulmonary function Exclusion Criteria: * Patients with abnormal findings on electrocardiogram before surgery * Patients who cannot undergo peripheral venous puncture

Primary outcome measure(s)

  • Pulse pressure variation — intraoperative period
    from arterial waveform

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Bundang Hospital Seongnam-si Gyunggi-do
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06734650 on ClinicalTrials.gov ↗ ← All trials in South Korea