Actively Recruiting

Age: 19Years +
All Genders
Healthy Volunteers
NCT07260890

Paired Comparison of SVV and PVI Accuracy

Led by Wonkwang University Hospital · Updated on 2025-12-29

300

Participants Needed

1

Research Sites

21 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Paired Comparison of SVV and PVI Accuracy

Who Can Participate

Age: 19Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • ASA physical status I to III
  • Scheduled for elective laparoscopic major abdominal surgery under general anesthesia
  • Arterial line placed for clinical care
  • Able to provide informed consent
  • Adequate arterial and plethysmographic waveforms for measurement
Not Eligible

You will not qualify if you...

  • Clinically significant arrhythmia such as atrial fibrillation with irregular R-R intervals
  • Severe valvular heart disease or intracardiac shunt
  • Pregnancy
  • Severe right-heart failure or conditions making fluid bolus unsafe
  • Ongoing hemodynamic instability requiring rapid vasoactive drug changes
  • Persistently unreliable arterial or plethysmographic signals despite attempts to optimize
  • Any condition judged unsafe for fluid challenge by the anesthesiologist

AI-Screening

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Trial Site Locations

Total: 1 location

1

Wonkwang University School of Medicine Hospital

Iksan, Jeollabuk-do, South Korea, 54538

Actively Recruiting

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Research Team

C

Cheol Lee, MD,PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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