RecruitingNCT07260890

Paired Comparison of SVV and PVI Accuracy

Diagnostic Accuracy of Stroke Volume Variation (SVV) vs Pleth Variability Index (PVI) for Predicting Fluid Responsiveness in Laparoscopic Major Abdominal Surgery-A Prospective, Paired, Cohort Study


Sponsor

Wonkwang University Hospital

Enrollment

300 participants

Start Date

Oct 1, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 19 Years

Inclusion Criteria6

  • 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 Criteria7

  • 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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Interventions

DEVICEStroke Volume Variation (SVV) monitoring

Non-investigational physiologic monitoring. SVV derived from the invasive arterial pressure waveform using a commercially available platform. Used as an index test; values recorded immediately before and \~3 minutes after a standardized 250-mL crystalloid bolus at up to two time points (pre- and post-pneumoperitoneum). Readings are masked to clinicians; operation per usual care.

DEVICEPleth Variability Index (PVI) monitoring

Non-investigational pulse-oximetry-derived index. PVI obtained from a commercial monitor. Used as a paired index test; values recorded immediately before and \~3 minutes after each 250-mL crystalloid bolus (up to two time points). Readings masked; monitor used within standard care.


Locations(1)

Wonkwang University School of Medicine Hospital

Iksan, Jeollabuk-do, South Korea

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NCT07260890


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