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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke Volume Variation; Pleth Variability Index; Pulse Pressure Variation
• Intervention / Treatment: Other: peripheral waveform collection

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Insun Park, M.D./Ph.D.; Phone Number: 823178777499; Email: pis121@hanmail.net

Study Locations

• Korea, Republic of
  • Gyunggi-do
    • Seongnam-si, Gyunggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients scheduled for elective hepatectomy under general anesthesia

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

peripheral waveform collection group; Peripheral Venous Pressure Variation; Pulse Pressure Variation; Pleth Variability Index

Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluid responsiveness	Cardiac output increases by more than 15% after 250 mL crystalloid injection during a fluid challenge	intraoperative period

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Insun Park, Assistant Professor

Study record dates

Study Major Dates

• Study Start (Estimated): December 28, 2024
• Primary Completion (Estimated): November 28, 2025
• Study Completion (Estimated): November 28, 2026

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Actual): December 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: B-2412-941-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No