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

NCT06734650 | Not Yet Recruiting

• 1 other identifier: B-2411-936-303
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Pulse pressure variation

  from arterial waveform

  intraoperative period

Study Arms (1)

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

Interventions

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).

Peripheral waveform collection group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for elective hepatectomy under general anesthesia

You may qualify if:

• 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

You may not qualify if:

• Patients with abnormal findings on electrocardiogram before surgery
• Patients who cannot undergo peripheral venous puncture

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

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

Location

Study Officials

• Insun Park, M.D./Ph.D.

  assistant professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

82317877499; pis121@hanmail.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 16, 2024
• Study Start: December 28, 2024
• Primary Completion: November 28, 2025
• Study Completion (Estimated): November 28, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

KR (1)