NCT06981221

PVI Predictors in Laparoscopic Hysterectomy

Predictors of Pleth Variability Index During Laparoscopically Assisted Vaginal Hysterectomy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Wonkwang University Hospital · Academic / Other
• Sex: Female
• Age: 19 Years – 70 Years
• Healthy volunteers: —

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.

Detailed description

This prospective, single-center observational cohort study evaluates dynamic intraoperative changes in the Pleth Variability Index (PVI) in 50 adult female patients undergoing elective laparoscopically assisted vaginal hysterectomy (LAVH) at Wonkwang University Hospital. After establishing euvolemia with a 500 mL Volulyte preload (Fresenius Kabi GmbH) over 30-50 minutes, no further intraoperative fluid boluses are given. Anesthesia is induced with propofol (2 mg/kg), fentanyl (1-2 μg/kg), and rocuronium (0.6 mg/kg), and maintained with sevoflurane or desflurane titrated to a bispectral index (BIS) of 40-60. Pneumoperitoneum is set at 12-15 mmHg, and positional maneuvers include 30° passive leg raising, 15° Trendelenburg, and 15° reverse Trendelenburg. Monitoring devices and data acquisition: * \*\*Masimo Radical-7\*\* pulse oximeter (PVI, perfusion index \[PI\]) * \*\*Invasive arterial line\*\* (mean arterial pressure \[MAP\]) * \*\*BIS sensor\*\* (BIS) * \*\*Skin temperature probe\*\* (forearm, °C) calibrated pre-case Measurements are recorded at six standardized time points (baseline; post-induction; post-passive leg raising; post-pneumoperitoneum; post-Trendelenburg; post-reverse Trendelenburg). Continuous waveforms are averaged over 30 s epochs. Primary endpoint is the absolute change in PVI (ΔPVI) relative to baseline. Secondary analyses include: * Multivariable logistic regression for predictors of ΔPVI ≥ 5% * Multivariable linear regression for continuous ΔPVI prediction * Correlation analyses of ΔPVI with intraabdominal pressure (mmHg) and body mass index (kg/m²) * Sensitivity analysis of PI reliability (intraclass correlation coefficient) across skin temperature thresholds * Descriptive statistics for frequency of vasopressor (ephedrine) use All analyses are performed using SPSS v29.0 with p \< 0.05 considered statistically significant (Bonferroni correction applied for repeated measures).

Conditions

• Hysterectomy
• PVI
• Fluid Responsiveness

Interventions

Type	Name	Description
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."

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-04-30
• Completion: 2025-05-05
• First posted: 2025-05-20
• Last updated: 2025-05-20

Locations

1 site across 1 country: South Korea