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

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

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 .

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke Volume Variation; Pulse Pressure Variation; Deep Learning Model; Arterial Wave Reflections; Peripheral Vein
• Intervention / Treatment: Other: peripheral waveform collection

Detailed Description

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 .

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Insun Park, M.D./Ph.D.; Phone Number: 82317877499; Email: pis121@hanmail.net

Study Locations

• Korea, Republic of
  • Gyunggi-do
    • Seongnam-si, Gyunggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients scheduled for elective hepatectomy under general anesthesia

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Peripheral waveform collection group; Peripheral Venous Pressure Variation; Stroke Volume Variation; Pulse Pressure Variation; Pleth Variability Index

Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse pressure variation	from arterial waveform	intraoperative period

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Insun Park, M.D./Ph.D., Assistant Professor

Study record dates

Study Major Dates

• Study Start (Estimated): December 28, 2024
• Primary Completion (Estimated): November 28, 2025
• Study Completion (Estimated): November 28, 2026

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: B-2411-936-303

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No