Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2018-04-19
2019-01-09
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Patients undergoing major upper abdominal surgery
major open upper abdominal surgery eg pancreatic, liver surgery
carotid blood flow measurement with ultrasound
carotid blood flow measurement with ultrasound vs transpulmonary thermodilution calibrated continuous cardiac output measurements
Interventions
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carotid blood flow measurement with ultrasound
carotid blood flow measurement with ultrasound vs transpulmonary thermodilution calibrated continuous cardiac output measurements
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Invasive arterial blood pressure monitoring
* Informed consent
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Philips Healthcare
INDUSTRY
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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A.P.J. Vlaar
Principal investigator
Principal Investigators
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A.P. Vlaar, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Amsterdam UMC
Locations
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Academisch Medisch Centrum - Universiteit van Amsterdam
Amsterdam, , Netherlands
Countries
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Other Identifiers
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NL64436.018.17
Identifier Type: -
Identifier Source: org_study_id
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