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Starting soon Observational

Peripheral Venous Pressure Variation, Pulse Pressure Variation and Pleth Variability Index for Fluid Responsiveness

NCT06733389 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2024-12-28
Last updated
2024-12-17

Condition(s) studied

Pulse Pressure VariationStroke Volume VariationPleth Variability Index

Investigational drug(s) / intervention(s)

peripheral waveform collection

peripheral waveform collection: The peripheral venous pressure is collected by connecting a pressure transducer that is currently in use to the central venous line. In addition, pulse pressure variation and stroke volume variation that can be obtained from the arterial catheter. In addition, the pleth variability index is collected through the oxygen saturation monitoring. 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 Algorithms' (B-2202-738-401).

Study summary

Pulse pressure variation (PPV) and pleth variability index (PVI) are widely used in clinical practice as indicators of the responsiveness to fluid therapy in patients receiving mechanical ventilation. PPV, which measures changes in arterial pressure, requires arterial puncture, which is invasive, and PVI, which detects subtle changes in oxygen saturation, requires an expensive, commercial monitoring equipment. In this study, we aimed to measure peripheral venous pressure variation using less invasive waveform variation in peripheral veins and to determine whether this indicator can be clinically used to predict the responsiveness to fluid therapy. In addition, the investigators aimed to confirm the superiority of the indicators by comparing them with the responsiveness to fluid therapy of the PPV and PVI.

Eligibility

Sex
ALL
Min age
19 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Patients voluntarily agreed and signed the written informed consent form before participating in the study * Adults 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

Primary outcome measure(s)

  • Fluid responsiveness — intraoperative period
    Cardiac output increases by more than 15% after 250 mL crystalloid injection during a fluid challenge

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Bundang Hospital Seongnam-si Gyunggi-do
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06733389 on ClinicalTrials.gov ↗ ← All trials in South Korea