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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04593797
Acronym
EFLOW
Enrollment
20
Registered
2020-10-20
Start date
2018-04-19
Completion date
2019-01-09
Last updated
2020-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Output, High, Cardiac Output, Low

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 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.

Interventions

DIAGNOSTIC_TESTcarotid blood flow measurement with ultrasound

carotid blood flow measurement with ultrasound vs transpulmonary thermodilution calibrated continuous cardiac output measurements

Sponsors

Philips Healthcare
CollaboratorINDUSTRY
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Elective open GI surgery * Invasive arterial blood pressure monitoring * Informed consent

Exclusion criteria

* Significant stenosis \> 30% or abnormal anatomy of aortic, femoral, carotid or brachial artery * Cerebrovascular accident * Atrial fibrillation * COPD stage 3-4 * Lobectomy / pneumectomy * Active pneumonia * Cardiac failure * Severe heart valve regurgitation or stenosis * Not able to measure brachial or carotid artery blood flow during surgery * Contra-indications for femoral arterial catheter placement (e.g., vascular graft)

Design outcomes

Primary

MeasureTime frameDescription
Cardiac outputbaselineblood flow determined by ultrasound and the accuracy compared to transpulmonary thermodilution calibrated continuous cardiac output

Secondary

MeasureTime frameDescription
Cardiac output changechange from baseline cardiac output 1 minute after intervention (fluid challenge, vasopressor administration, or Trendelenburg)Change in blood flow compared to change in cardiac output

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026