Health TrialsbyHealthPanel

Paired Comparison of SVV and PVI Accuracy

ConditionsPerioperative CareFluid TherapyMonitoring, PhysiologicHemodynamicsLaparoscopy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorWonkwang University Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥18 years

ASA physical status I-III

Elective laparoscopic major abdominal surgery under general anesthesia

Arterial line in place for clinical care

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Laparoscopic Surgery Cohort2 interventions

Trial outcomes

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).

Time frame
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

1

Sensitivity of prespecified SVV thresholds for predicting fluid responsiveness

Proportion of fluid challenges in which SVV \> 13% correctly identifies fluid responsiveness (≥10% increase in stroke volume index after a 250 mL bolus).Unit of Measure: Percent of fluid challenges (%)

Time frame
Intraoperative: pre-bolus baseline to about 3 minutes after each 250 mL bolus (up to two boluses).
2

Specificity of prespecified SVV thresholds for predicting fluid responsiveness

Proportion of fluid challenges in which SVV ≤ 13% correctly identifies non-responsiveness. Unit of Measure: Percent of fluid challenges (%)

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

Sensitivity of prespecified PVI threshold for predicting fluid responsiveness

Description: Proportion of fluid challenges in which PVI \> 15% correctly identifies fluid responsiveness (≥10% increase in stroke volume index). Unit of Measure: Percent of fluid challenges (%)

Time frame
Intraoperative: pre bolus baseline to about 3 minutes after each 250 mL bolus (up to two episodes per participant).
4

Specificity of prespecified PVI threshold for predicting fluid responsiveness

Proportion of fluid challenges in which PVI ≤ 15% correctly identifies non-responsiveness. Unit of Measure: Percent of fluid challenges (%)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wonkwang University Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now