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

Not yet recruiting

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

• Registration Number: NCT06734650
• Lead Sponsor: Seoul National University Bundang Hospital

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 .

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 Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Study First Posted: 2024-12-16
• Last Update Posted: 2024-12-16
• Study Start: 2024-12-28
• Primary Completion: 2025-11-28
• Study Completion: 2026-11-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulse pressure variation	intraoperative period	from arterial waveform

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyunggi-do, Korea, Republic of