Comparing SVV and PVI monitors to predict fluid responsiveness during laparoscopic abdominal surgery
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
This test will see if SVV (from an arterial line) or PVI (from a pulse oximeter) better predicts whether a small fluid bolus will help the heart pump more effectively in adults having elective laparoscopic major abdominal surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Wonkwang University Hospital Academic / other |
| Locations | 1 site (Iksan, Jeollabuk-do) |
| Trial ID | NCT07260890 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center paired diagnostic accuracy comparison of two non‑experimental monitors (SVV and PVI) in adults undergoing elective laparoscopic major abdominal surgery. Each participant receives up to two standardized 250‑mL crystalloid boluses (one before and one after pneumoperitoneum) given over about three minutes as part of routine care, while SVV and PVI values are recorded and hidden from clinicians. The primary outcome is the area under the ROC curve (AUROC) for predicting fluid responsiveness, with secondary analyses to define optimal thresholds and assess effects of pneumoperitoneum, BMI, ventilation, and vasoactive drug use. No investigational drugs or devices are used and risks are limited to those of small fluid boluses.
Who should consider this trial
Good fit: Adults (age ≥18) with ASA physical status I–III scheduled for elective laparoscopic major abdominal surgery who have an arterial line and reliable arterial and plethysmographic waveforms are ideal candidates.
Not a fit: Patients with clinically significant arrhythmias, severe valvular disease or intracardiac shunt, severe right‑heart failure, pregnancy, ongoing hemodynamic instability, or persistently unreliable arterial/pleth signals are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, clinicians could use the more accurate monitor to guide fluid therapy during laparoscopy, helping to avoid under‑ or over‑resuscitation and improve patient safety.
How similar studies have performed: Prior research on SVV and PVI during pneumoperitoneum and positional changes has shown mixed and inconsistent results, so a direct paired comparison is needed to clarify which performs better.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Iksan, Jeollabuk-do
- Wonkwang University School of Medicine Hospital — Iksan, Jeollabuk-do, South Korea (Recruiting)
Study contacts
- Principal investigator: Cheolhyeong Lee, MD, PhD — Wonkwang University School of Medicine Hospital
- Study coordinator: Cheol Lee, MD,PhD
- Email: ironyii70@gmail.com
- Phone: +82-859-1564
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.