PVI Predictors in Laparoscopic Hysterectomy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age19-70
SponsorWonkwang University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adult females aged 19-70 years (American Society of Anesthesiologists physical status I-III) scheduled for elective LAVH.
Disqualifiers
emergency surgery, severe cardiac or pulmonary disease, renal failure, pregnancy, or conditions contraindicating fluid administration. Participants were consecutively recruited during preoperative consultations.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
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."
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
ΔPVI (Change in Pleth Variability Index)
Absolute change in PVI (%) at each of six intraoperative time points relative to baseline.
Time frame
Intraoperative period (~60-90 minutes)Secondary outcomes
1
Proportion of patients with significant ΔPVI ≥ 5%
Percentage of participants exhibiting a ΔPVI ≥ 5% at any intraoperative time point.
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)2
Effect of intraabdominal pressure on ΔPVI
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.
Time frame
At post-pneumoperitoneum and post-Trendelenburg time points (20-45 minutes after anesthesia induction)3
Effect of body mass index on ΔPVI
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.
Time frame
ΔPVI measured at post-pneumoperitoneum and post-Trendelenburg time points (20-45 minutes after anesthesia induction)4
Change in mean arterial pressure (MAP)
Absolute change in MAP (mmHg) at the six predefined time points.
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)Sponsors and contacts
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Source ClinicalTrials.gov