Cardiac Output, LowEFLOWNCT04593797
Echo FLOW Versus (Non-)Invasive Haemodynamics
An observational study of Cardiac Output, Low and Cardiac Output, High, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Output, Low, Cardiac Output, High
- What is being tested?
- carotid blood flow measurement with ultrasound
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Apr 2018to 9 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients, scheduled for open upper GI surgery with a American Society of Anaesthesiologist score of 1 to 2
Who may be able to join
- Elective open GI surgery
- Invasive arterial blood pressure monitoring
- Informed consent
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academisch Medisch Centrum - Universiteit van Amsterdam
Amsterdam
About this study
Official title: The Accuracy of Ultrasound Derived Carotid, Femoral and Brachial Artery Compared to Conventional Intra-vascular Methods Flow-related Parameters
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.
Read more
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
- Being tested
- carotid blood flow measurement with ultrasound
- Medical subject headings
- Cardiac Output, Low, Cardiac Output, High
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carotid blood flow measurement with ultrasoundDiagnostic test
Also called transpulmonary thermodilution calibrated continuous cardiac output measurements
carotid blood flow measurement with ultrasound vs transpulmonary thermodilution calibrated continuous cardiac output measurements
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing major upper abdominal surgery | major open upper abdominal surgery eg pancreatic, liver surgery Receives: Diagnostic Test: carotid blood flow measurement with ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output
blood flow determined by ultrasound and the accuracy compared to transpulmonary thermodilution calibrated continuous cardiac output
Measured: baseline
Secondary outcomes (1)
Cardiac output change
Change in blood flow compared to change in cardiac output
Measured: change from baseline cardiac output 1 minute after intervention (fluid challenge, vasopressor administration, or Trendelenburg)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start19 Apr 2018
- Primary completion9 Jan 2019
- Study completion9 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Output, LowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare
- Responsible party
- Principal investigator, A.P.J. Vlaar, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- A.P. Vlaar, MD, PhD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593797
- Sponsor's protocol ID
- NL64436.018.17
- Acronym
- EFLOW
- Status last verified
- Oct 2020
- First submitted
- 29 Sep 2020
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Plan to make individual available upon request
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Ultrasound Derived Carotid, Femoral and Brachial Artery Compared to Conventional Intra-vascular Methods Flow-related Parameters
- ClinicalTrials.gov ID
- NCT04593797
- Acronym / sponsor ID
- EFLOW / NL64436.018.17
- Conditions
- Cardiac Output, Low, Cardiac Output, High
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Philips Healthcare
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 9 Jan 2019 (actual)
- Study completion
- 9 Jan 2019 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing major upper abdominal surgery | – | Diagnostic Test: carotid blood flow measurement with ultrasoundmajor open upper abdominal surgery eg pancreatic, liver surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients, scheduled for open upper GI surgery with a American Society of Anaesthesiologist score of 1 to 2
Key inclusion criteria (3 listed)
- Elective open GI surgery
- Invasive arterial blood pressure monitoring
- Informed consent
Key exclusion criteria (10 listed)
- Significant stenosis > 30% or abnormal anatomy of aortic, femoral, carotid or brachial artery
- Cerebrovascular accident
- Atrial fibrillation
- COPD stage 3-4
- Lobectomy / pneumectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carotid blood flow measurement with ultrasoundAlso: transpulmonary thermodilution calibrated continuous cardiac output measurementscarotid blood flow measurement with ultrasound vs transpulmonary thermodilution calibrated continuous cardiac output measurements | Diagnostic test | Patients undergoing major upper abdominal surgery |
Primary outcome
Cardiac output
Time frame: baseline
blood flow determined by ultrasound and the accuracy compared to transpulmonary thermodilution calibrated continuous cardiac output
1 secondary outcome
Cardiac output change
Time frame: change from baseline cardiac output 1 minute after intervention (fluid challenge, vasopressor administration, or Trendelenburg)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Individual participant dataSharing planned: Undecided. Plan to make individual available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A.P. Vlaar, MD, PhD principal investigator
Amsterdam UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Output, Low and Cardiac Output, High, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.