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

Universitair Ziekenhuis Brussel

Status: Terminated

Conditions: Aneurysm; Carotid Artery Plaque; Aortic Aneurysm

Treatments: Procedure: Cytocam-IDF

Study type: Interventional

Funder types: Other

Identifiers

NCT04913493

FLOMIC

Details and patient eligibility

About

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).

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Control group

No Intervention group

Description:

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

Experimental group

Experimental group

Description:

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

Treatment:

Procedure: Cytocam-IDF