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

NCT06188039 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-01-06

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Superior vena cava collapsibility index

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.

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.

Sponsors & Collaborators

  • Uniwersytecki Szpital Kliniczny w Opolu

    lead OTHER

Principal Investigators

  • Tomasz Królicki, MD, PhD · Uniwersytecki Szpital Kliniczny w Opolu

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-03
Primary Completion
2025-11-17
Completion
2025-11-18

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06188039 on ClinicalTrials.gov