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

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.

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Key information

Conditions

Pulse Pressure Variation Pleth Variability Index Stroke Volume Variation

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

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

About this study

Pulse pressure variation (PPV) and pleth variability index (PVI) are widely used in clinical practice as indicators of the responsiveness to fluid therapy. The investigators 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

peripheral waveform collection

Other

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).

Primary outcomes

Fluid responsiveness

Time frame: intraoperative period

Cardiac output increases by more than 15% after 250 mL crystalloid injection during a fluid challenge

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

823178777499

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Comparison of Peripheral Venous Pressure Variation, Pulse Pressure Variation and Pleth Variability Index in Predicting Fluid Responsiveness

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Dec 13, 2024
Registry last updated: Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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