Ignite Creation Date:
2024-05-06 @ 4:13 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04913493
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-01
First Post:
2021-04-27
Brief Title:
Use of Sublingual Microcirculation and FloTrac Monitoring During Major Vascular Surgery and Its Effect on Hospital LOS
Sponsor:
Universitair Ziekenhuis Brussel
Organization:
Universitair Ziekenhuis Brussel
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
the aim of this study is to determine whether an intraoperative optimization protocol using the enhanced flow-based hemodynamic parameters of the FloTracVigileo 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 FloTracVigileo monitoring alone
The FloTracVigileo 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
The FloTracVigileo 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None