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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06734650
Enrollment
150
Registered
2024-12-16
Start date
2024-12-28
Completion date
2026-11-28
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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 .

Interventions

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).

Sponsors

Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pulse pressure variationintraoperative periodfrom arterial waveform

Countries

South Korea

Contacts

Primary ContactInsun Park, M.D./Ph.D.
pis121@hanmail.net82317877499

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026