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

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 .

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Key information

Conditions

Peripheral Vein Arterial Wave Reflections Deep Learning Model Pulse Pressure Variation Stroke Volume Variation

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyunggi-do, 13620, South Korea

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

peripheral waveform collection

Other

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).

Primary outcomes

Pulse pressure variation

Time frame: intraoperative period

from arterial waveform

Study contacts

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

Insun Park, M.D./Ph.D.

CONTACT

[email protected]

82317877499

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Development and Validation of a Peripheral Venous Waveform-based Pulse Pressure Variation Calculating Deep Learning Model

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Dec 16, 2024
Registry last updated: Dec 16, 2024

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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