Echo FLOW Versus (Non-)Invasive Haemodynamics

Cardiac Output, Low Clinical Trial

— EFLOW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04593797
• Other study ID #: NL64436.018.17
• Status: Completed
• Start date: April 19, 2018
• Est. completion date: January 9, 2019

Study information

• Verified date: October 2020
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 9, 2019
• Est. primary completion date: January 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiac Output, High
• Cardiac Output, Low

Intervention

Diagnostic Test:
• carotid blood flow measurement with ultrasound
carotid blood flow measurement with ultrasound vs transpulmonary thermodilution calibrated continuous cardiac output measurements

Locations

Country	Name	City	State
Netherlands	Academisch Medisch Centrum - Universiteit van Amsterdam	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Philips Healthcare

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac output	blood flow determined by ultrasound and the accuracy compared to transpulmonary thermodilution calibrated continuous cardiac output	baseline
Secondary	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)