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

NCT06733389 | Not Yet Recruiting

• 1 other identifier: B-2412-941-301
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulse Pressure Variation; Stroke Volume Variation; Pleth Variability Index

Outcome Measures

Primary Outcomes (1)

• Fluid responsiveness

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

  intraoperative period

Study Arms (1)

peripheral waveform collection group

1. Peripheral Venous Pressure Variation 2. Pulse Pressure Variation 3. Pleth Variability Index

Other: peripheral waveform collection

Interventions

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).

peripheral waveform collection group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for elective hepatectomy under general anesthesia

You may qualify if:

• 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

You may not qualify if:

• Patients with abnormal findings on electrocardiogram before surgery
• Patients who cannot undergo peripheral venous puncture

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

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

Location

Study Officials

• Insun Park

  assistant professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

823178777499; pis121@hanmail.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: December 28, 2024
• Primary Completion: November 28, 2025
• Study Completion (Estimated): November 28, 2026
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

KR (1)