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

Not Applicable

Active, not recruiting

• Conditions: Carotid Artery Plaque; Aortic Aneurysm; Aneurysm
• Interventions: Procedure: Cytocam-IDF

• Registration Number: NCT04913493
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-05-28
• Study First Posted: 2021-06-04
• Study Start: 2021-06-08
• Status Verified: 2023-04
• Primary Completion: 2023-04-01
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 22

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Cytocam-IDF	Patients will receive an additional medical imaging intervention. Namely sublingual microcirculation imaging with Cytocam-IDF.

Primary Outcome Measures

Name	Time	Method
Number of hospitalisation days. (LOS)	up to 30 Days	How long is the hospital Length-Of-Stay?

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Jette, Brussel, Belgium