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

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ClinicalTrials.gov Identifier: NCT04593797
Recruitment Status : Completed
First Posted : October 20, 2020
Last Update Posted : October 20, 2020
Sponsor:
Collaborator:
Philips Healthcare
Information provided by (Responsible Party):
A.P.J. Vlaar, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Description
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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.


Condition or disease Intervention/treatment
Cardiac Output, Low Cardiac Output, High Diagnostic Test: carotid blood flow measurement with ultrasound

Study Design
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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Accuracy of Ultrasound Derived Carotid, Femoral and Brachial Artery Compared to Conventional Intra-vascular Methods Flow-related Parameters
Actual Study Start Date : April 19, 2018
Actual Primary Completion Date : January 9, 2019
Actual Study Completion Date : January 9, 2019
Groups and Cohorts
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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 Name: transpulmonary thermodilution calibrated continuous cardiac output measurements


Outcome Measures
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Primary Outcome Measures :
  1. Cardiac output [ Time Frame: baseline ]
    blood flow determined by ultrasound and the accuracy compared to transpulmonary thermodilution calibrated continuous cardiac output


Secondary Outcome Measures :
  1. Cardiac output change [ Time Frame: change from baseline cardiac output 1 minute after intervention (fluid challenge, vasopressor administration, or Trendelenburg) ]
    Change in blood flow compared to change in cardiac output


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04593797


Locations
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Netherlands
Academisch Medisch Centrum - Universiteit van Amsterdam
Amsterdam, Netherlands
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Philips Healthcare
Investigators
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Principal Investigator: A.P. Vlaar, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
More Information
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Responsible Party: A.P.J. Vlaar, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT04593797    
Other Study ID Numbers: NL64436.018.17
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Plan to make individual available upon request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiac Output, Low
Cardiac Output, High
Heart Diseases
Cardiovascular Diseases