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Not Yet RecruitingNCT06734650

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

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
150 (estimated)
Sponsor
Seoul National University Bundang Hospital · Academic / Other
Sex
All
Age
19 Years – 80 Years
Healthy volunteers
Accepted

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 .

Conditions

Interventions

TypeNameDescription
OTHERperipheral waveform collectionThe 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).

Timeline

Start date
2024-12-28
Primary completion
2025-11-28
Completion
2026-11-28
First posted
2024-12-16
Last updated
2024-12-16

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT06734650. Inclusion in this directory is not an endorsement.