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

NCT06188039 | Completed

• 1 other identifier: W27/KB/2023_TK
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgery; Fluid Responsiveness; Transesophageal Echocardiography

Keywords

Fluid responsiveness; non-cardiac surgery; Superior vena cava collapsibility index; echocardiography

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

Patients undergoing open aortic surgery with sinus rhythm

EXPERIMENTAL

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

Patients undergoing laparotomy and high PEEP

EXPERIMENTAL

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; Other: PEEP elevation

Patients undergoing laparotomy with standard ventilatory settings

ACTIVE COMPARATOR

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

Interventions

Superior vena cava collapsibility index DIAGNOSTIC_TEST

After induction of general anaesthesia following interventions will be performed. 1. Insertion of a tranesophageal echocardiography probe 2. Measurement of SVC-CI 3. Measurement of LVOT-VTI prior to fluid bolus 4. Fluid bolus (250ml of crystalloid) 5. 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.

Also known as: SVC-CI, fluid bolus, transesophageal echocardiography

Patients undergoing laparotomy and high PEEP; Patients undergoing laparotomy with standard ventilatory settings; Patients undergoing open aortic surgery with sinus rhythm

PEEP elevation OTHER

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.

Patients undergoing laparotomy and high PEEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Uniwersytecki Szpital Kliniczny w Opolu: lead

Study Sites (1)

Opole University Hospital

Opole, 45-401, Poland

Location

MeSH Terms

Interventions

Echocardiography, Transesophageal

Intervention Hierarchy (Ancestors)

Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Tomasz Królicki, MD, PhD

  Uniwersytecki Szpital Kliniczny w Opolu

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: January 3, 2024
• Study Start: January 3, 2024
• Primary Completion: November 17, 2025
• Study Completion: November 18, 2025
• Last Updated: January 6, 2026

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)