Carotid Artery PlaqueNCT04913493
Use of Sublingual Microcirculation and FloTrac Monitoring During Major Vascular Surgery and Its Effect on Hospital LOS
A study testing Cytocam-IDF in people with Carotid Artery Plaque and Aortic Aneurysm, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Plaque, Aortic Aneurysm, Aneurysm
- What is being tested?
- Cytocam-IDF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Jun 2021to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Cytocam-IDF
- Medical subject headings
- Carotid Stenosis, Aortic Aneurysm, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytocam-IDFProcedure or surgery
Patients receive an extra medical imaging test perioperatively with the Cytocam-IDF
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Cytocam-IDF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hospitalisation days. (LOS)
How long is the hospital Length-Of-Stay?
Measured: up to 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start8 Jun 2021
- Primary completion1 Apr 2023
- Study completion1 Dec 2023
Why it stopped: Not enough patient recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery PlaqueStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène De Cuyper, MD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913493
- Sponsor's protocol ID
- FLOMIC
- Status last verified
- Apr 2023
- First submitted
- 27 Apr 2021
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients individual data will not be shared. Findings of the study will be published in a scientific article.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04913493
- Acronym / sponsor ID
- FLOMIC
- Conditions
- Carotid Artery Plaque, Aortic Aneurysm, Aneurysm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough patient recruited
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients will only receive FloTrac/Vigileo monitoring which is standard of care. |
| Experimental group | Experimental | Procedure: Cytocam-IDFPatients will receive an additional medical imaging intervention. Namely sublingual microcirculation imaging with Cytocam-IDF. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- Age < 18 years
- Presence of permanent cardiac arrythmias
- Weight < 55kg and > 140kg
- Pregnancy
- Emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytocam-IDFPatients receive an extra medical imaging test perioperatively with the Cytocam-IDF | Procedure or surgery | Experimental group |
Primary outcome
Number of hospitalisation days. (LOS)
Time frame: up to 30 Days
How long is the hospital Length-Of-Stay?
Results and safety
The study was stopped early (reason given: Not enough patient recruited). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No. Patients individual data will not be shared. Findings of the study will be published in a scientific article.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hélène De Cuyper, MD principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cytocam-IDF in people with Carotid Artery Plaque and Aortic Aneurysm, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not enough patient recruited). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hospitalisation days. (LOS) (time frame: up to 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.