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

December 12, 2024 updated by: Park InSun, Seoul National University Bundang Hospital

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Peripheral waveform collection group
  1. Peripheral Venous Pressure Variation
  2. Stroke Volume Variation
  3. Pulse Pressure Variation
  4. 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
Time Frame: intraoperative period
from arterial waveform
intraoperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Insun Park, M.D./Ph.D., Assistant Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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