NCT06981221 PVI Predictors in Laparoscopic Hysterectomy
| NCT ID | NCT06981221 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wonkwang University Hospital |
| Condition | Hysterectomy |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2026-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2026-07-01 with a primary completion date of 2026-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Cheol Lee, M.D.,Ph.D
STUDY DIRECTOR
Wonkwang University Hospital
Frequently Asked Questions
Who can join the NCT06981221 clinical trial?
This trial is open to female participants only, aged 19 Years or older, up to 70 Years, studying Hysterectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06981221 currently recruiting?
Yes, NCT06981221 is actively recruiting participants. Contact the research team at ironyii@wku.ac.kr for enrollment information.
Where is the NCT06981221 trial being conducted?
This trial is being conducted at Iksan, South Korea.
Who is sponsoring the NCT06981221 clinical trial?
NCT06981221 is sponsored by Wonkwang University Hospital. The principal investigator is Cheol Lee, M.D.,Ph.D at Wonkwang University Hospital. The trial plans to enroll 50 participants.