MedPath

Echo FLOW Versus (Non-)Invasive Haemodynamics

Completed
Conditions
Cardiac Output, High
Cardiac Output, Low
Interventions
Diagnostic Test: carotid blood flow measurement with ultrasound
Registration Number
NCT04593797
Lead Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Patients undergoing major upper abdominal surgerycarotid blood flow measurement with ultrasoundmajor open upper abdominal surgery eg pancreatic, liver surgery
Primary Outcome Measures
NameTimeMethod
Cardiac outputbaseline

blood flow determined by ultrasound and the accuracy compared to transpulmonary thermodilution calibrated continuous cardiac output

Secondary Outcome Measures
NameTimeMethod
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

Trial Locations

Locations (1)

Academisch Medisch Centrum - Universiteit van Amsterdam

🇳🇱

Amsterdam, Netherlands

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