HysterectomyNCT06981221
PVI Predictors in Laparoscopic Hysterectomy
An observational study of Hysterectomy and PVI, run by Wonkwang University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 70 years, women only
- Conditions the study is for
- Hysterectomy, PVI, Fluid Responsiveness
- What is being tested?
- Masimo Radical-7 Pulse Oximeter
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2026to 12 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- Women only
- Adult, Older adult
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.
Who may be able to join
- adult females aged 19-70 years (American Society of Anesthesiologists physical status I-III) scheduled for elective LAVH.
Who cannot join
- emergency surgery, severe cardiac or pulmonary disease, renal failure, pregnancy, or conditions contraindicating fluid administration. Participants were consecutively recruited during preoperative consultations.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Wonkwang University School of Medicine Hospital
Iksan, Jeollabuk-do, 54538
About this study
Official title: 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.
Read the 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).
- Conditions
- Hysterectomy, PVI, Fluid Responsiveness
- Being tested
- Masimo Radical-7 Pulse Oximeter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo Radical-7 Pulse OximeterDevice
Also called PVI (Pleth Variability Index)
"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."
What is being measured
The primary outcome is the main question the study is designed to answer.
ΔPVI (Change in Pleth Variability Index)
Absolute change in PVI (%) at each of six intraoperative time points relative to baseline.
Measured: Intraoperative period (~60-90 minutes)
Secondary outcomes (8)
Proportion of patients with significant ΔPVI ≥ 5%
Percentage of participants exhibiting a ΔPVI ≥ 5% at any intraoperative time point.
Measured: 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
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.
Measured: At post-pneumoperitoneum and post-Trendelenburg time points (20-45 minutes after anesthesia induction)
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.
Measured: ΔPVI measured at post-pneumoperitoneum and post-Trendelenburg time points (20-45 minutes after anesthesia induction)
Change in mean arterial pressure (MAP)
Absolute change in MAP (mmHg) at the six predefined time points.
Measured: 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)
Absolute change in PI (unitless) at the six predefined time points.
Measured: 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)
Absolute change in BIS (unitless) at the six predefined time points.
Measured: 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
Difference in intraclass correlation coefficient of PI measurements between stable (≤ ± 1 °C) and decreased (> 1 °C drop) skin temperature conditions.
Measured: 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
Number and percentage of patients requiring ephedrine bolus due to MAP < 70 mmHg during the observation period.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 Jul 2026
- Primary completion10 Jul 2026
- Study completion12 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wonkwang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheol Lee,MD,PhD,, Wonkwang University Hospital
- Investigators
- Cheol Lee, M.D.,Ph.D, Study director, Wonkwang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981221
- Sponsor's protocol ID
- Wonkwang UH19
- Status last verified
- Aug 2026
- First submitted
- 7 May 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Pleth Variability Index During Laparoscopically Assisted Vaginal Hysterectomy
- ClinicalTrials.gov ID
- NCT06981221
- Acronym / sponsor ID
- Wonkwang UH19
- Conditions
- Hysterectomy, PVI, Fluid Responsiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Wonkwang University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 10 Jul 2026 (actual)
- Study completion
- 12 Aug 2026 (actual)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- adult females aged 19-70 years (American Society of Anesthesiologists physical status I-III) scheduled for elective LAVH.
Key exclusion criteria (1 listed)
- emergency surgery, severe cardiac or pulmonary disease, renal failure, pregnancy, or conditions contraindicating fluid administration. Participants were consecutively recruited during preoperative consultations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Masimo Radical-7 Pulse OximeterAlso: PVI (Pleth Variability Index)"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." | Device | – |
Primary outcome
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.
8 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheol Lee, M.D.,Ph.D study director
Wonkwang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hysterectomy and PVI, run by Wonkwang University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ΔPVI (Change in Pleth Variability Index) (time frame: Intraoperative period (~60-90 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026; AzTrials last refreshed its copy on 31 Oct 2026.