NCT07260890Completed
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
Source: ClinicalTrials.gov · Last updated 14 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 300 (actual)
- First submitted
- 13 Nov 2025
- Start date
- 1 Jul 2026
- Primary completion date
- 15 Jul 2026
- Lead sponsor
- Wonkwang University Hospital
- Diseases
- Stroke
- NCT number
- NCT07260890
What you commit to
- Study type: Observational
- Participants enrolled: 300
- From 1 Jul 2026 to the primary completion date, 15 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- linically significant arrhythmia (e.g., atrial fibrillation with irregular R-R)
- Severe valvular heart disease or intracardiac shunt
- Severe right-heart failure or condition where a fluid bolus is unsafe
Other
- Pregnancy
- 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
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wonkwang University School of Medicine Hospital Coordinator of this site? Confirm its status | Iksan | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.