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| Name | Class |
|---|---|
| Philips Healthcare | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing major upper abdominal surgery | major open upper abdominal surgery eg pancreatic, liver surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carotid blood flow measurement with ultrasound | Diagnostic Test | carotid blood flow measurement with ultrasound vs transpulmonary thermodilution calibrated continuous cardiac output measurements |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac output | blood flow determined by ultrasound and the accuracy compared to transpulmonary thermodilution calibrated continuous cardiac output | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients, scheduled for open upper GI surgery with a American Society of Anaesthesiologist score of 1 to 2
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| Name | Affiliation | Role |
|---|---|---|
| A.P. Vlaar, MD, PhD | Amsterdam UMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academisch Medisch Centrum - Universiteit van Amsterdam | Amsterdam | Netherlands |
Plan to make individual available upon request
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| ID | Term |
|---|---|
| D002303 | Cardiac Output, Low |
| D016534 | Cardiac Output, High |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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