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

Sponsor

Universitair Ziekenhuis Brussel (Other)

Overall Status

Recruiting

CT.gov ID

NCT04913493

Collaborator

(none)

Enrollment

Location

Arms

16.8

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Carotid Artery Plaque Aortic Aneurysm Aneurysm	Procedure: Cytocam-IDF	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 8, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

No Intervention: Control group

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

Experimental: Experimental group

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

Procedure: Cytocam-IDF

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Brussel	Jette	Brussel	Belgium	1090

Sponsors and Collaborators

Universitair Ziekenhuis Brussel

Investigators

Principal Investigator: Hélène De Cuyper, MD, Universitair Ziekenhuis Brussel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universitair Ziekenhuis Brussel

ClinicalTrials.gov Identifier:

NCT04913493

Other Study ID Numbers:

FLOMIC

First Posted:

Jun 4, 2021

Last Update Posted:

Nov 10, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Carotid Stenosis

Aneurysm

Aortic Aneurysm

Study Results

No Results Posted as of Nov 10, 2021