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NCT04913493

Use of Sublingual Microcirculation and FloTrac Monitoring During Major Vascular Surgery and Its Effect on Hospital LOS

Terminated NA Last updated 18 December 2025
What this trial tests

NA trial testing Cytocam-IDF in Carotid Artery Plaque in 22 participants. Terminated before completion.

Timeline
8 June 2021
Primary endpoint
1 April 2023
1 December 2023

Quick facts

Lead sponsorUniversitair Ziekenhuis Brussel
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment22
Start date8 June 2021
Primary completion1 April 2023
Estimated completion1 December 2023
Sites1 location across Belgium

Drugs / interventions tested

Conditions studied

Sponsor

Universitair Ziekenhuis Brussel — full company profile →

Who can join

18 and older, any sex, with Carotid Artery Plaque or Aortic Aneurysm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

the aim of this study is to determine whether an intraoperative optimization protocol using the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device in combination with intraoperative measurement of the sublingual microcirculation with the Cytocam-IDF device would result in an improvement in outcome in high-risk patients undergoing major vascular surgery, measured by the hospital LOS in comparison with intraoperative FloTrac/Vigileo monitoring alone. The FloTrac/Vigileo device only needs standard arterial access for enhanced, flow-based hemodynamic monitoring. It is reported to be easy to use and easy to set up and calculates the stroke volume (SV) on the basis of the arterial waveform in combination with demographic data. Cardiac index (CI), stroke volume index (SVI) as an indicator for fluid status and stroke volume variation (SVV) as an indicator for fluid responsiveness during mechanical ventilation and sinus rhythm will be continuously measured during major vascular procedures, including carotid endarterectomy (CEA), open abdominal aortic aneurysm (AAA) repair , endovascular aneurysm repair (EVAR), thoracic endovascular aneurysm repair (TEVAR) and fenestrated endovascular aneurysm repair (FEVAR).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Carotid Artery Plaque

Currently open trials in the same condition.

Other Universitair Ziekenhuis Brussel trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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