Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04593797
Status:
COMPLETED
Last Update Posted:
2020-10-20
First Post:
2020-09-29
Brief Title:
Echo FLOW Versus Non-Invasive Haemodynamics
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
The Accuracy of Ultrasound Derived Carotid Femoral and Brachial Artery Compared to Conventional Intra-vascular Methods Flow-related Parameters
Status:
COMPLETED
Status Verified Date:
2020-10
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:
EFLOW
Brief Summary:
Rationale Diligent fluid management is instrumental to improve postoperative outcome cost and quality of care
Objective To determine the accuracy of brachial femoral and carotid blood flow measurement with ultrasound compared to intermittent transpulmonary thermodilution cardiac output measurement invasive and non-invasive pulse-contour analysis
Study design Observational study - Prospective clinical non-intervention measurement study
Study population Adult ASA 1-2 patients scheduled for open upper GI surgery Intervention if applicable Not applicable We will perform non-invasive ultrasound measurements of the femoral carotid and brachial blood flow right before induction and under anaesthesia
Main study parametersendpoints Femoral carotid and brachial blood flow determined by ultrasound and blood flow variation and the accuracy compared to transpulmonary thermodilution cardiac output stroke volume variation and pulse-contour analysis derived cardiac output invasive or non-invasive at the following time points during surgery limited for femoral site as it cannot be measured during surgery 1 before induction of anaesthesia 2 after induction 3 15 minutes after start of surgery 4 before and 5 after 1-2 minutes a fluid bolus 6 before and 7 after start of vasopressors 8 before and 9 after Trendelenburg position and 10 after surgery before end of anaesthesia figure 1 A fluid bolus will be performed as part of standard care goal-directed fluid therapy The vasopressor and Trendelenburg position time points are optional measurements We will also measure continuous invasive femoral blood pressure SBP DBP MAP non-invasive blood pressure SVV central venous pressure when available heart rate SpO2 PFI etCO2
Objective To determine the accuracy of brachial femoral and carotid blood flow measurement with ultrasound compared to intermittent transpulmonary thermodilution cardiac output measurement invasive and non-invasive pulse-contour analysis
Study design Observational study - Prospective clinical non-intervention measurement study
Study population Adult ASA 1-2 patients scheduled for open upper GI surgery Intervention if applicable Not applicable We will perform non-invasive ultrasound measurements of the femoral carotid and brachial blood flow right before induction and under anaesthesia
Main study parametersendpoints Femoral carotid and brachial blood flow determined by ultrasound and blood flow variation and the accuracy compared to transpulmonary thermodilution cardiac output stroke volume variation and pulse-contour analysis derived cardiac output invasive or non-invasive at the following time points during surgery limited for femoral site as it cannot be measured during surgery 1 before induction of anaesthesia 2 after induction 3 15 minutes after start of surgery 4 before and 5 after 1-2 minutes a fluid bolus 6 before and 7 after start of vasopressors 8 before and 9 after Trendelenburg position and 10 after surgery before end of anaesthesia figure 1 A fluid bolus will be performed as part of standard care goal-directed fluid therapy The vasopressor and Trendelenburg position time points are optional measurements We will also measure continuous invasive femoral blood pressure SBP DBP MAP non-invasive blood pressure SVV central venous pressure when available heart rate SpO2 PFI etCO2
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?:
None
Is an FDA AA801 Violation?:
None