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Paired Comparison of SVV and PVI Accuracy

NCT07260890 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-12-29

No results posted yet for this study

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.

Conditions

  • Perioperative Care
  • Fluid Therapy
  • Monitoring, Physiologic
  • Hemodynamics
  • Laparoscopy

Interventions

DEVICE

Stroke 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.

DEVICE

Pleth 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.

Sponsors & Collaborators

  • Wonkwang University Hospital

    lead OTHER

Principal Investigators

  • Cheolhyeong Lee, MD, PhD · Wonkwang University School of Medicine Hospital

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2025-10-22
Completion
2026-03-01

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07260890 on ClinicalTrials.gov