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Clinical Trials/NCT04913493
NCT04913493
Terminated
Not Applicable

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

Universitair Ziekenhuis Brussel1 site in 1 country22 target enrollmentJune 8, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carotid Artery Plaque
Sponsor
Universitair Ziekenhuis Brussel
Enrollment
22
Locations
1
Primary Endpoint
Number of hospitalisation days. (LOS)
Status
Terminated
Last Updated
4 months ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
June 8, 2021
End Date
December 1, 2023
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Number of hospitalisation days. (LOS)

Time Frame: up to 30 Days

How long is the hospital Length-Of-Stay?

Study Sites (1)

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