PVI Predictors in Laparoscopic Hysterectomy

August 12, 2026 updated by: Cheol Lee,MD,PhD,, Wonkwang University Hospital

Predictors of Pleth Variability Index During Laparoscopically Assisted Vaginal 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Device: Masimo Radical-7 Pulse Oximeter

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).

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

South Korea
- Jeollabuk-do
  - Iksan, Jeollabuk-do, South Korea, 54538
    - Wonkwang University School of Medicine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult female patients aged 19 to 70 years with ASA physical status I-III who are scheduled to undergo elective laparoscopic-assisted vaginal hysterectomy (LAVH) at Wonkwang University Hospital. All participants are screened during routine preoperative consultations and provide written informed consent prior to enrollment.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Intraoperative period (~60-90 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	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.	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)	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.	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)	Absolute change in MAP (mmHg) at the six predefined time points.	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)	Absolute change in PI (unitless) at the six predefined time points.	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)	Absolute change in BIS (unitless) at the six predefined time points.	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)	Difference in intraclass correlation coefficient of PI measurements between stable (≤ ± 1 °C) and decreased (> 1 °C drop) skin temperature conditions.	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)	Number and percentage of patients requiring ephedrine bolus due to MAP < 70 mmHg during the observation period.	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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wonkwang University Hospital

Investigators

Study Director: Cheol Lee, M.D.,Ph.D, Wonkwang University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2026

Primary Completion (Actual)

July 10, 2026

Study Completion (Actual)

August 12, 2026

Study Registration Dates

First Submitted

May 7, 2025

First Submitted That Met QC Criteria

May 18, 2025

First Posted (Actual)

May 20, 2025

Study Record Updates

Last Update Posted (Actual)

August 14, 2026

Last Update Submitted That Met QC Criteria