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PVI Predictors in Laparoscopic Hysterectomy

NCT06981221 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-08-14

No results posted yet for this study

Summary

This observational study investigates the predictors of Pleth Variability Index (PVI) changes in euvolemic patients undergoing laparoscopic-assisted vaginal hysterectomy (LAVH). The primary objective is to quantify changes in PVI (ΔPVI) across six intraoperative time points associated with positional shifts. Secondary objectives include identifying key predictors of significant PVI change (ΔPVI ≥ 5%), such as passive leg raising, Trendelenburg position, body mass index (BMI), and intraabdominal pressure. Additional variables including perfusion index, mean arterial pressure, bispectral index, skin temperature, age, and anesthetic agent will be evaluated as potential modulators. Findings aim to support individualized fluid management strategies in LAVH.

Conditions

  • Hysterectomy
  • PVI
  • Fluid Responsiveness

Interventions

DEVICE

Masimo Radical-7 Pulse Oximeter

"PVI is continuously monitored using the Masimo Radical-7 pulse oximetry device to evaluate respiratory variation in the plethysmographic waveform amplitude during laparoscopic-assisted vaginal hysterectomy (LAVH). No fluid intervention is applied; device use is for observational measurement of fluid responsiveness."

Sponsors & Collaborators

  • Wonkwang University Hospital

    lead OTHER

Principal Investigators

  • Cheol Lee, M.D.,Ph.D · Wonkwang University Hospital

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2026-07-10
Completion
2026-08-12

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06981221 on ClinicalTrials.gov