PVI Predictors in Laparoscopic Hysterectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Masimo Radical-7 Pulse Oximeter.
- Who it may be relevant to
- Registry conditions: Hysterectomy, PVI, Fluid Responsiveness. Basic parameters: 19 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Predictors of Pleth Variability Index During Laparoscopically Assisted Vaginal Hysterectomy
Overview
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).
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."
Primary outcome measures
- ΔPVI (Change in Pleth Variability Index) [Time frame: Intraoperative period (~60-90 minutes)]
Secondary outcome measures (8)
- Proportion of patients with significant ΔPVI ≥ 5% [Time frame: At any of the six predefined intraoperative time points: • Post-induction • Post-passive leg raising • Post-pneumoperitoneum • Post-Trendelenburg • Post-reverse Trendelenburg • End of surgery (within 60-90 minutes after induction of anesthesia)]
- Effect of intraabdominal pressure on ΔPVI [Time frame: At post-pneumoperitoneum and post-Trendelenburg time points (20-45 minutes after anesthesia induction)]
- Effect of body mass index on ΔPVI [Time frame: ΔPVI measured at post-pneumoperitoneum and post-Trendelenburg time points (20-45 minutes after anesthesia induction)]
- Change in mean arterial pressure (MAP) [Time frame: MAP measured at six predefined intraoperative time points: • Baseline • Post-induction • Post-passive leg raising • Post-pneumoperitoneum • Post-Trendelenburg • Post-reverse Trendelenburg (Total duration: ~90 minutes after anesthesia induction)]
- Change in perfusion index (PI) [Time frame: MAP measured at six predefined intraoperative time points: • Baseline • Post-induction • Post-passive leg raising • Post-pneumoperitoneum • Post-Trendelenburg • Post-reverse Trendelenburg (Total duration: ~90 minutes after anesthesia induction)]
- Change in bispectral index (BIS) [Time frame: MAP measured at six predefined intraoperative time points: • Baseline • Post-induction • Post-passive leg raising • Post-pneumoperitoneum • Post-Trendelenburg • Post-reverse Trendelenburg (Total duration: ~90 minutes after anesthesia induction)]
- Influence of skin temperature on PI reliability [Time frame: MAP measured at six predefined intraoperative time points: • Baseline • Post-induction • Post-passive leg raising • Post-pneumoperitoneum • Post-Trendelenburg • Post-reverse Trendelenburg (Total duration: ~90 minutes after anesthesia induction)]
- Frequency of vasopressor use [Time frame: MAP measured at six predefined intraoperative time points: • Baseline • Post-induction • Post-passive leg raising • Post-pneumoperitoneum • Post-Trendelenburg • Post-reverse Trendelenburg (Total duration: ~90 minutes after anesthesia induction)]
Eligibility criteria
Inclusion criteria
- adult females aged 19-70 years (American Society of Anesthesiologists physical status I-III) scheduled for elective LAVH.
Exclusion criteria
- emergency surgery, severe cardiac or pulmonary disease, renal failure, pregnancy, or conditions contraindicating fluid administration. Participants were consecutively recruited during preoperative consultations.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Wonkwang University School of Medicine Hospital — Iksan
Identifiers
NCT: NCT06981221 · Wonkwang UH19