NCT04913493

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Carotid Artery Plaque
• Aortic Aneurysm
• Aneurysm

Interventions

Type	Name	Description
PROCEDURE	Cytocam-IDF	Patients receive an extra medical imaging test perioperatively with the Cytocam-IDF

Timeline

• Start date: 2021-06-08
• Primary completion: 2023-04-01
• Completion: 2023-12-01
• First posted: 2021-06-04
• Last updated: 2025-12-18

Locations

1 site across 1 country: Belgium