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

NCT04913493 | Terminated

• 1 other identifier: FLOMIC
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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).

Conditions

Carotid Artery Plaque; Aortic Aneurysm; Aneurysm

Outcome Measures

Primary Outcomes (1)

• Number of hospitalisation days. (LOS)

  How long is the hospital Length-Of-Stay?

  up to 30 Days

Study Arms (2)

Control group

NO INTERVENTION

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

Experimental group

EXPERIMENTAL

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

Procedure: Cytocam-IDF

Interventions

Cytocam-IDF PROCEDURE

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

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

Carotid Stenosis; Aortic Aneurysm; Aneurysm

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Hélène De Cuyper, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: June 4, 2021
• Study Start: June 8, 2021
• Primary Completion: April 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 18, 2025

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)