PVI Predictors in Laparoscopic Hysterectomy

NCT06981221 | Completed DMC

• 1 other identifier: Wonkwang UH19
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• ΔPVI (Change in Pleth Variability Index)

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

  Intraoperative period (~60-90 minutes)

Secondary Outcomes (8)

• Proportion of patients with significant ΔPVI ≥ 5%

  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

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

• Effect of body mass index on ΔPVI

  ΔPVI measured at post-pneumoperitoneum and post-Trendelenburg time points (20-45 minutes after anesthesia induction)

• Change in mean arterial pressure (MAP)

  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)

  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)

Interventions

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."

Also known as: PVI (Pleth Variability Index)

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• adult females aged 19-70 years (American Society of Anesthesiologists physical status I-III) scheduled for elective LAVH.

You may not qualify if:

• emergency surgery, severe cardiac or pulmonary disease, renal failure, pregnancy, or conditions contraindicating fluid administration. Participants were consecutively recruited during preoperative consultations.

Sponsors & Collaborators

• Wonkwang University Hospital: lead

Study Sites (1)

Wonkwang University School of Medicine Hospital

Iksan, Jeollabuk-do, 54538, South Korea

Location

Study Officials

• Cheol Lee, M.D.,Ph.D

  Wonkwang University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 20, 2025
• Study Start: April 1, 2025
• Primary Completion: April 30, 2025
• Study Completion: May 5, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

KR (1)