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Recruiting NCT07260890

Paired Comparison of SVV and PVI Accuracy

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Trial Parameters

Condition Perioperative Care
Sponsor Wonkwang University Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 300
Sex ALL
Min Age 19 Years
Max Age N/A
Start Date 2025-10-01
Completion 2025-10-22
Interventions
Stroke Volume Variation (SVV) monitoringPleth Variability Index (PVI) monitoring

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Brief Summary

This study will compare two operating-room monitors-stroke volume variation (SVV, from the arterial line) and the Pleth Variability Index (PVI, from the pulse oximeter)-to see which one more accurately predicts whether giving a small fluid bolus will improve the heart's pumping during laparoscopic major abdominal surgery. Adults having elective surgery under general anesthesia will receive two small, timed 250-mL crystalloid infusions as part of routine care (one before and one after creation of the pneumoperitoneum). The research team will record SVV and PVI values just before and three minutes after each infusion while keeping these readings hidden from the clinicians so that usual care is not changed. No experimental drugs or devices are used. The main goal is to learn which index better identifies "fluid responsiveness," so future care can be safer and more consistent. Potential risks are minimal and relate to the small fluid boluses (temporary changes in blood pressure or heart rate); the test stops if the anesthesiologist has any safety concerns. There is no direct benefit to participants, but results may help guide fluid therapy for similar patients in the future. The study is being conducted at a single academic hospital in the Republic of Korea and plans to enroll about 300 adults.

Eligibility Criteria

Inclusion Criteria: * Age ≥18 years * ASA physical status I-III * Elective laparoscopic major abdominal surgery under general anesthesia * Arterial line in place for clinical care * Able to provide informed consent * Arterial and plethysmographic waveforms adequate for measurement Exclusion Criteria: * linically significant arrhythmia (e.g., atrial fibrillation with irregular R-R) * Severe valvular heart disease or intracardiac shunt * Pregnancy * Severe right-heart failure or condition where a fluid bolus is unsafe * Ongoing hemodynamic instability requiring rapid vasoactive titration at assessment * Persistently unreliable arterial/pleth signals despite optimization * Any situation the anesthesiologist judges that the fluid challenge is unsafe

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