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

Study Overview
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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).

Official Title
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Use of Sublingual Microcirculation and FloTrac Monitoring During Major Vascular Surgery and Its Effect on Hospital Length of Stay: a Prospective Cohort Study

Conditions
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Carotid Artery Plaque, Aortic Aneurysm, Aneurysm

Intervention / Treatment
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* Procedure: Cytocam-IDF


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Patients will only receive FloTrac/Vigileo monitoring which is standard of care. | |
| Experimental: Experimental group<br>Patients will receive an additional medical imaging intervention. Namely sublingual microcirculation imaging with Cytocam-IDF. | Procedure: Cytocam-IDF<br>* Patients receive an extra medical imaging test perioperatively with the Cytocam-IDF<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hospitalisation days. (LOS) | How long is the hospital Length-Of-Stay? | up to 30 Days |