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NCT Number: NCT06981221

PVI Predictors in Laparoscopic Hysterectomy

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.

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Key information

Age range

19 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Wonkwang University School of Medicine Hospital

Iksan, Jeollabuk-do, 54538, South Korea

Location status: Recruiting

Location contact

Cheol Lee, M.D.,Ph.D.

CONTACT

[email protected]

01066131252

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Masimo Radical-7 Pulse Oximeter

Device

"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."

Other names: PVI (Pleth Variability Index)

Primary outcomes

  1. ΔPVI (Change in Pleth Variability Index)

    Time frame: Intraoperative period (~60-90 minutes)

    Absolute change in PVI (%) at each of six intraoperative time points relative to baseline.

Secondary outcomes

  1. 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)

    Percentage of participants exhibiting a ΔPVI ≥ 5% at any intraoperative time point.

  2. Effect of intraabdominal pressure on ΔPVI

    Time frame: At post-pneumoperitoneum and post-Trendelenburg time points (20-45 minutes after anesthesia induction)

    Correlation coefficient (r) between intraabdominal pressure (mmHg) and magnitude of ΔPVI.with magnitude of ΔPVI during pneumoperitoneum and Trendelenburg position. Multivariable linear regression is used.

  3. 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)

    Correlation coefficient (r) between BMI (kg/m²) and magnitude of ΔPVI.measurements during LAVH. Data analyzed using subgroup comparison between stable and decreased skin temperature conditions.

  4. 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)

    Absolute change in MAP (mmHg) at the six predefined time points.

  5. 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)

    Absolute change in PI (unitless) at the six predefined time points.

  6. 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)

    Absolute change in BIS (unitless) at the six predefined time points.

  7. 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)

    Difference in intraclass correlation coefficient of PI measurements between stable (≤ ± 1 °C) and decreased (> 1 °C drop) skin temperature conditions.

  8. 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)

    Number and percentage of patients requiring ephedrine bolus due to MAP < 70 mmHg during the observation period.

Study contacts

Contact information is provided by the study sponsor or research team.

Cheol Lee, M.D.,Ph.D

CONTACT

[email protected]

01066131252

Cheolhyeong Lee, M.D.

CONTACT

[email protected]

01066131252

Sponsors and collaborators

Lead sponsor

Wonkwang University Hospital

Other

Registry information

Official study title

Predictors of Pleth Variability Index During Laparoscopically Assisted Vaginal Hysterectomy

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 20, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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