Clinical trial NCT04593797: Echo FLOW Versus (Non-)Invasive Haemodynamics
Official title: The Accuracy of Ultrasound Derived Carotid, Femoral and Brachial Artery Compared to Conventional Intra-vascular Methods Flow-related Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Output, Low
Cardiac Output, High
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
First posted: 2020-10-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Cardiac output
timeFrame: baseline
Secondary outcomes:
measure: Cardiac output change
timeFrame: change from baseline cardiac output 1 minute after intervention (fluid challenge, vasopressor administration, or Trendelenburg)
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum - Universiteit van Amsterdam
Study officials:
affiliation: Amsterdam UMC
name: A.P. Vlaar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: