NCT04593797

Echo FLOW Versus (Non-)Invasive Haemodynamics

The Accuracy of Ultrasound Derived Carotid, Femoral and Brachial Artery Compared to Conventional Intra-vascular Methods Flow-related Parameters

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 parameters/endpoints: 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.

Conditions

• Cardiac Output, Low
• Cardiac Output, High

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	carotid blood flow measurement with ultrasound	carotid blood flow measurement with ultrasound vs transpulmonary thermodilution calibrated continuous cardiac output measurements

Timeline

• Start date: 2018-04-19
• Primary completion: 2019-01-09
• Completion: 2019-01-09
• First posted: 2020-10-20
• Last updated: 2020-10-20

Locations

1 site across 1 country: Netherlands