Echo FLOW Versus (Non-)Invasive Haemodynamics

NCT04593797 | Completed

• 1 other identifier: NL64436.018.17
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Output, Low; Cardiac Output, High

Outcome Measures

Primary Outcomes (1)

• Cardiac output

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

  baseline

Secondary Outcomes (1)

• Cardiac output change

  change from baseline cardiac output 1 minute after intervention (fluid challenge, vasopressor administration, or Trendelenburg)

Study Arms (1)

Patients undergoing major upper abdominal surgery

major open upper abdominal surgery eg pancreatic, liver surgery

Diagnostic Test: carotid blood flow measurement with ultrasound

Interventions

carotid blood flow measurement with ultrasound DIAGNOSTIC_TEST

carotid blood flow measurement with ultrasound vs transpulmonary thermodilution calibrated continuous cardiac output measurements

Also known as: transpulmonary thermodilution calibrated continuous cardiac output measurements

Patients undergoing major upper abdominal surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Elective open GI surgery
• Invasive arterial blood pressure monitoring
• Informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Philips Healthcare: collaborator

Study Sites (1)

Academisch Medisch Centrum - Universiteit van Amsterdam

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Cardiac Output, Low; Cardiac Output, High

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• A.P. Vlaar, MD, PhD

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 20, 2020
• Study Start: April 19, 2018
• Primary Completion: January 9, 2019
• Study Completion: January 9, 2019
• Last Updated: October 20, 2020

Record last verified: 2020-10

Locations

NL (1)