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

NCT ID: NCT04913493

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-08

Study Completion Date

2023-12-01

Brief Summary

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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).

Detailed Description

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Conditions

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Carotid Artery Plaque Aortic Aneurysm Aneurysm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

Patients will only receive FloTrac/Vigileo monitoring which is standard of care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental group

Patients will receive an additional medical imaging intervention. Namely sublingual microcirculation imaging with Cytocam-IDF.

Group Type EXPERIMENTAL

Cytocam-IDF

Intervention Type PROCEDURE

Patients receive an extra medical imaging test perioperatively with the Cytocam-IDF

Interventions

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Cytocam-IDF

Patients receive an extra medical imaging test perioperatively with the Cytocam-IDF

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Males and females
* ASA III classification
* Written informed consent obtained by the patient
* Elective hospital admission for major vascular surgery procedures (CEA, open AAA, EVAR, TEVAR, FEVAR)

Exclusion Criteria

* Age \< 18 years
* Presence of permanent cardiac arrythmias
* Weight \< 55kg and \> 140kg
* Pregnancy
* Emergency surgery
* Minor vascular procedures
* Refusal or inability to provide written informed consent (language barrier, mental retardation, dementia)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hélène De Cuyper, MD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

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UZ Brussel

Jette, Brussels Capital, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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FLOMIC

Identifier Type: -

Identifier Source: org_study_id