Use of Sublingual Microcirculation and FloTrac Monitoring During Major Vascular Surgery and Its Effect on Hospital LOS
Primary Purpose
Carotid Artery Plaque, Aortic Aneurysm, Aneurysm
Status
Active
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Cytocam-IDF
Sponsored by
About this trial
This is an interventional treatment trial for Carotid Artery Plaque
Eligibility Criteria
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)
Sites / Locations
- UZ Brussel
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Experimental group
Arm Description
Patients will only receive FloTrac/Vigileo monitoring which is standard of care.
Patients will receive an additional medical imaging intervention. Namely sublingual microcirculation imaging with Cytocam-IDF.
Outcomes
Primary Outcome Measures
Number of hospitalisation days. (LOS)
How long is the hospital Length-Of-Stay?
Secondary Outcome Measures
Full Information
NCT ID
NCT04913493
First Posted
April 27, 2021
Last Updated
April 28, 2023
Sponsor
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT04913493
Brief Title
Use of Sublingual Microcirculation and FloTrac Monitoring During Major Vascular Surgery and Its Effect on Hospital LOS
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 8, 2021 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Plaque, Aortic Aneurysm, Aneurysm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients will only receive FloTrac/Vigileo monitoring which is standard of care.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Patients will receive an additional medical imaging intervention. Namely sublingual microcirculation imaging with Cytocam-IDF.
Intervention Type
Procedure
Intervention Name(s)
Cytocam-IDF
Intervention Description
Patients receive an extra medical imaging test perioperatively with the Cytocam-IDF
Primary Outcome Measure Information:
Title
Number of hospitalisation days. (LOS)
Description
How long is the hospital Length-Of-Stay?
Time Frame
up to 30 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hélène De Cuyper, MD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Brussel
City
Jette
State/Province
Brussel
ZIP/Postal Code
1090
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Patients individual data will not be shared. Findings of the study will be published in a scientific article.
Learn more about this trial
Use of Sublingual Microcirculation and FloTrac Monitoring During Major Vascular Surgery and Its Effect on Hospital LOS
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