Echo FLOW Versus (Non-)Invasive Haemodynamics (EFLOW)

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Output, Low; Cardiac Output, High
• Intervention / Treatment: Diagnostic test: carotid blood flow measurement with ultrasound

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Academisch Medisch Centrum - Universiteit van Amsterdam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients, scheduled for open upper GI surgery with a American Society of Anaesthesiologist score of 1 to 2

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing major upper abdominal surgery; major open upper abdominal surgery eg pancreatic, liver surgery	Diagnostic test: carotid blood flow measurement with ultrasound; carotid blood flow measurement with ultrasound vs transpulmonary thermodilution calibrated continuous cardiac output measurements; Other Names: transpulmonary thermodilution calibrated continuous cardiac output measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac output	blood flow determined by ultrasound and the accuracy compared to transpulmonary thermodilution calibrated continuous cardiac output	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac output change	Change in blood flow compared to change in cardiac output	change from baseline cardiac output 1 minute after intervention (fluid challenge, vasopressor administration, or Trendelenburg)

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: Philips Healthcare
• Investigators: Principal Investigator: A.P. Vlaar, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 19, 2018
• Primary Completion (ACTUAL): January 9, 2019
• Study Completion (ACTUAL): January 9, 2019

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (ACTUAL): October 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 20, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiac Output, Low; Cardiac Output, High
• Other Study ID Numbers: NL64436.018.17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Plan to make individual available upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No