Paired Comparison of SVV and PVI Accuracy

NCT07260890 | Recruiting DMC

• 1 other identifier: Wonkwang UH 22
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

stroke volume variation; SVV; Pleth Variability Index; PVI; fluid responsiveness; goal-directed fluid therapy; GDFT; pneumoperitoneum; diagnostic accuracy; ROC; AUROC

Outcome Measures

Primary Outcomes (1)

• Area under the ROC curve (AUROC) of stroke volume variation (SVV) and Pleth Variability Index (PVI) for predicting fluid responsiveness to a 250-mL crystalloid bolus

  Index tests: pre-bolus SVV (arterial waveform-derived) and PVI (pulse-oximetry-derived). Reference standard: fluid responsiveness defined as a \>=10% increase in stroke volume index measured about 3 minutes after the 250-mL crystalloid bolus using arterial pulse contour analysis. ROC curves will be built for SVV and PVI to discriminate responders vs non-responders; AUROCs will be compared with a paired DeLong test with patient-level clustering. Unit: AUROC (0-1; higher indicates better discrimination).

  Intraoperative: from the pre-bolus baseline to ~3 minutes after each standardized 250-mL crystalloid bolus (up to two episodes per participant: before and after pneumoperitoneum).

Secondary Outcomes (10)

• Sensitivity of prespecified SVV thresholds for predicting fluid responsiveness

  Intraoperative: pre-bolus baseline to about 3 minutes after each 250 mL bolus (up to two boluses).

• Specificity of prespecified SVV thresholds for predicting fluid responsiveness

  Intraoperative: pre bolus baseline to about 3 minutes after each 250 mL bolus (up to two episodes per participant).

• Sensitivity of prespecified PVI threshold for predicting fluid responsiveness

  Intraoperative: pre bolus baseline to about 3 minutes after each 250 mL bolus (up to two episodes per participant).

• Specificity of prespecified PVI threshold for predicting fluid responsiveness

  Intraoperative: pre bolus baseline to about 3 minutes after each 250 mL bolus (up to two episodes per participant).

• Optimal cutoffs for SVV using Youden index

  Intraoperative: pre bolus to about 3 minutes post bolus.

Study Arms (1)

Laparoscopic Surgery Cohort

Adults undergoing elective laparoscopic major abdominal surgery under general anesthesia at a single academic hospital. Each participant may receive up to two standardized 250-mL crystalloid fluid challenges (pre- and post-pneumoperitoneum). SVV and PVI are recorded around each bolus; no assignment or experimental treatment.

Device: Stroke Volume Variation (SVV) monitoring; Device: Pleth Variability Index (PVI) monitoring

Interventions

Stroke Volume Variation (SVV) monitoring DEVICE

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.

Also known as: SVV, Arterial pressure waveform analysis, FloTrac, EV1000, HemoSphere, Edwards Lifesciences

Laparoscopic Surgery Cohort

Pleth Variability Index (PVI) monitoring DEVICE

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.

Also known as: PVI, Pleth variability Index, Pulse oximetry-derived variability, Masimo, Radical-7

Laparoscopic Surgery Cohort

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults undergoing elective laparoscopic major abdominal surgery at a single academic hospital.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wonkwang University Hospital: lead

Study Sites (1)

Wonkwang University School of Medicine Hospital

Iksan, Jeollabuk-do, 54538, South Korea

RECRUITING

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Study Officials

• Cheolhyeong Lee, MD, PhD

  Wonkwang University School of Medicine Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheol Lee, MD,PhD

CONTACT

+82-859-1564; ironyii70@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: December 3, 2025
• Study Start: October 1, 2025
• Primary Completion: October 22, 2025
• Study Completion: March 1, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

KR (1)