Superior Vena Cava Collapsibility Index for Predicting Fluid Responsiveness During High-risk Non-cardiac Surgery (PRESCIENCE)

Predicting Fluid REsponsiveness Using Superior Vena Cava Collapsibility IndEx duriNg High-risk Non-Cardiac surgEry (PRESCIENCE)

The goal of this prospective study is to validate the superior vena cava collapsibility index (SVC-CI) as a predictor of fluid responsiveness during laparotomy and open aortic surgery. The SVC-CI and patients' response to fluid will be assessed based on transesophageal echocardiography.

The study has three arms, in order to validate SVC-CI under the conditions of laparotomy, aortic cross clamping and high PEEP levels. One of the study arms will be an active comparator arm.

The data obtained from this study may help physicians guide intraoperative fluid therapy in a more efficient manner, in order to decrease perioperative mortality.

Study Overview

• Status: Completed
• Conditions: Surgery; Fluid Responsiveness; Transesophageal Echocardiography
• Intervention / Treatment: Diagnostic test: Superior vena cava collapsibility index; Other: PEEP elevation

Detailed Description

Patients undergoing high-risk non-cardiac surgery, including acute laparotomies and open aortic surgery, are at high risk of postoperative complications and adverse cardiovascular events. Perioperative fluid therapy is a factor which is strongly associated with postoperative outcomes. To avoid both hypovolemia and excessive fluid administration a strategy of goal-directed fluid therapy (GDFT) has been coined. Traditionally in the setting of operating rooms GDFT relied on stroke-volume variation (SVV) measured by hemodynamic monitors, based on uncalibrated pulse contour cardiac output analysis (uAPCO). However in the described cohort of patients uAPCO methods show a significantly increased measurement error, which is mainly attributed to dynamic changes in peripheral vascular tone. Furthermore, frequent occurrence of arhytmias in those patients limits the use of SVV and all other dynamic indices of fluid responsiveness based on those methods. Superior vena cava collapsibility index (SVC-CI) is a parameter which is devoid of the above mentioned limitations. It relies on respiratory variation of superior vena cava during the respiratory cycle and is therefore reliable in patients with irregular heart rhytm and seems independent from changing afterload conditions.

The main purpose of this study is to validate SVC-CI in patients undergoing controlled mechanical ventilation during laparotomies and during open aortic surgery, with focus on elevated PEEP levels and aortic cross-clamping.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Opole, Poland, 45-401
    • Opole University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Signed ICF (informed consent form)
• Age > 18 years old Eligibility criteria for each arm (additionally to mandatory criteria)
• Arm 1 - Patients undergoing open aortic surgery
• Arm 2 - Patients undergoing laparotomy
• Arm 3 - Patients undergoing laparotomy with sinus rhytm

Exclusion Criteria:

1. Patients who are deemed to be at risk of harm due to excessive fluid administration:

   • End-stage renal disease (eGFR <15ml/kg/min)
   • Decompensated heart failure
   • Respiratory failure prior to surgery
   • Other cases where the risk of harm from fluid overload is assessed to be significant by the investigator

2. Medical contraindication to the use of transesophageal echocardiography:

   • Active ulcerative gastritis or bleeding from upper gastrointestinal tract
   • Past history of esophageal or gastric surgery
   • Esophageal varices or other esophageal disease (stricture, Barret's disease, perforation in the past, achalasia)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients undergoing open aortic surgery with sinus rhythm; Arm to validate SVC-CI during open aortic surgery with special focus of predicting FR during aortic cross clamping (n=50).	Diagnostic test: Superior vena cava collapsibility index; After induction of general anaesthesia following interventions will be performed.; Insertion of a tranesophageal echocardiography probe; Measurement of SVC-CI; Measurement of LVOT-VTI prior to fluid bolus; Fluid bolus (250ml of crystalloid); Measurement of LVOT-VTI after fluid bolus Several volume trials per patient will be allowed, until safety criteria are met. In such cases further testing will be stopped.; Other Names: fluid bolus; SVC-CI; transesophageal echocardiography
Experimental: Patients undergoing laparotomy and high PEEP; Arm designed to validate SVC-CI during laparotomy, ventilated with high PEEP levels (8-10cmH2O). PEEP will be raised transiently during measurements (n=50).	Diagnostic test: Superior vena cava collapsibility index; After induction of general anaesthesia following interventions will be performed.; Insertion of a tranesophageal echocardiography probe; Measurement of SVC-CI; Measurement of LVOT-VTI prior to fluid bolus; Fluid bolus (250ml of crystalloid); Measurement of LVOT-VTI after fluid bolus Several volume trials per patient will be allowed, until safety criteria are met. In such cases further testing will be stopped.; Other Names: fluid bolus; SVC-CI; transesophageal echocardiography; Other: PEEP elevation; A transient elevation of positive end-expiratory pressure (PEEP) will be applied, in order to validate SVC-CI in the setting of elevated PEEP. A PEEP level of 8-10cmH2O will be applied for 1 minute prior to every measurement of SVC-CI. Then the previous PEEP level will be reinstated.
Active Comparator: Patients undergoing laparotomy with standard ventilatory settings; Arm designed as an active comparator with standard (protective) ventilatory settings (n=50). Tidal volumes (Vt) will be set for 8ml/kg.	Diagnostic test: Superior vena cava collapsibility index; After induction of general anaesthesia following interventions will be performed.; Insertion of a tranesophageal echocardiography probe; Measurement of SVC-CI; Measurement of LVOT-VTI prior to fluid bolus; Fluid bolus (250ml of crystalloid); Measurement of LVOT-VTI after fluid bolus Several volume trials per patient will be allowed, until safety criteria are met. In such cases further testing will be stopped.; Other Names: fluid bolus; SVC-CI; transesophageal echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluid responsiveness	Fluid responsiveness was defined as an increase of 10% or more of cardiac output (CO) following an administered 250ml fluid bolus. Changes in CO will be estimated using changes in left ventricle outflow tract velocity time integral (LVOT-VTI) assessed by transesophageal echocardiography to avoid errors associated with measuring LVOT area, which is necessary to calculate CO.	Directly after infusing fluid bolus.

Collaborators and Investigators

• Sponsor: Uniwersytecki Szpital Kliniczny w Opolu
• Investigators: Study Chair: Tomasz Królicki, MD, PhD, Uniwersytecki Szpital Kliniczny w Opolu

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2024
• Primary Completion (Actual): November 17, 2025
• Study Completion (Actual): November 18, 2025

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: January 2, 2024
• First Posted (Actual): January 3, 2024

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 3, 2026
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: echocardiography; Fluid responsiveness; non-cardiac surgery; Superior vena cava collapsibility index
• Additional Relevant MeSH Terms: Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Echocardiography; Cardiac Imaging Techniques; Ultrasonography; Echocardiography, Transesophageal
• Other Study ID Numbers: W27/KB/2023_TK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will be shared in open access, however no plan has been designed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No