Hemodynamic MeasurementNCT06007196
Evaluation of Non-invasive Continuous Hemodynamic Measurement From Task Force CORE
An observational study of Hemodynamic Measurement and Non-invasive, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Validation of hemodynamic measurements using the non-invasive Task Force Core(R) and Task Force Cardio(R) device with invasive hemodynamic measurements using the thermodilution technique (PICCO device). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Measurement, Non-invasive, Cardiac Output
- What is being tested?
- non-invasive device (Task Force CORE(R) and Task Force CARDIO(R)
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteAustria
- Study dates
- 1 Sep 2023to 30 Sep 2024
- 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
- Adult, Older adult
Study population: Adult patients, who undergo major abdominal surgery, which will require extended hemodynamic monitoring.
Who may be able to join
- Adult patients (patients aged at least 18 years)
- Patients undergoing major abdominal surgery who require invasive extended hemodynamic monitoring (trans pulmonary thermodilution via PiCCO and invasive blood pressure monitoring with radial artery catheter) according to clinical standard of care
- Patients with intact perfusion of both hands evidenced by a positive Allen's test
- Patients given written informed consent to participate in the study
Who cannot join
- Patients with vascular impairments at the sites of non-invasive blood pressure measurement (fingers or upper arms)
- Patients with significant edema in the fingers
- Patients with ventricular assist devices or extracorporeal life-supporting devices
- Subjects not passing the Allen's test for both hands
- Patients who obtain vasoactive medications on the same arm as used for upper-arm Task Force blood pressure measurements
- Patients with a large lateral difference in blood pressure (> 15mmHg for systolic blood pressure and/or >10 mmHg for diastolic blood pressure) or with same arm measurement differences > 10 mmHg in systolic or diastolic blood pressure during assessment of lateral differences
- Patients who, in addition to invasive blood pressure monitoring, require non-invasive blood pressure measurements unrelated to the investigational device
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Graz
Graz, Styria, 8010
David West, MD, david.west@medunigraz.at
About this study
Official title: Performance Evaluation of Non-invasive Continuous Hemodynamic Measurement From Task Force(R) CORE Versus Invasive Reference
Validation of hemodynamic measurements using the non-invasive Task Force Core(R) and Task Force Cardio(R) device with invasive hemodynamic measurements using the thermodilution technique (PICCO device).
Read the detailed description
The investigational device, Task Force® CORE (TFC, CNSystems Medizintechnik GmbH, Graz, Austria) together with the Task Force® CARDIO (TFCARDIO, CNSystems Medizintechnik GmbH, Graz, Austria) medical device software, is a new CE-marked medical device for continuous non-invasive determination of blood pressure (BP), cardiac output (CO) and derived parameters based on the well established CNAP® (continuous non-invasive arterial pressure) technology by CNSystems. The primary aim of this prospective, method comparison, open, multi-center study is data acquisition for the performance evaluation of the TFC in comparison with invasive reference methods (i.e. transpulmonary thermodilution, invasive blood pressure with radial artery catheter). The setting of the study will be the Operating Room (OR). This setting allows the comparison of the investigational device's cardiac output (CO) to invasive CO as well as of BP and derived hemodynamic parameters like Stroke Volume (SV), and Systemic Vascular Resistance (SVR). Measurements will be performed during the perioperative period, starting 15 minutes after the first skin incision.
- Conditions
- Hemodynamic Measurement, Non-invasive, Cardiac Output
- Being tested
- non-invasive device (Task Force CORE(R) and Task Force CARDIO(R)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive device (Task Force CORE(R) and Task Force CARDIO(R)Device
Intraoperative cardiac output will be measured using the non-invasive device (Task Force CORE(R) and Task Force CARDIO(R) and will be compared with the invasive thermodilution method (PiCCO).
| Study group | Role | What they receive |
|---|---|---|
| Continuous non-invasive Hemodynamic Monitoring | Continuous non-invasive Hemodynamic Monitoring (Task Force CORE(R) and Task Force CARDIO(R)) will be compared to invasive thermodilution cardiac output measurements in all patients. Receives: Device: non-invasive device (Task Force CORE(R) and Task Force CARDIO(R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in intraoperative cardiac output measurements between Task Force CORE compared with thermodilution during surgery
Intraoperative performance of cardiac output values derived by the Task Force CORE system compared with cardiac output measurements derived by thermodilution measurements.
Measured: For the duration of surgery
Secondary outcomes (4)
Differences in intraoperative hemodynamic measurements (blood pressure in mmHg) between Task Force CORE compared with thermodilution during surgery
Intraoperative evaluation of the performance of Task Force variable blood pressure (in mmHg) throughout surgery compared to simultaneous invasive measurements.
Measured: For the duration of surgery
Differences in intraoperative hemodynamic measurements (stroke volume in ml) between Task Force CORE compared with thermodilution during surgery
Intraoperative evaluation of the performance of Task Force variable stroke volume (in ml) throughout surgery compared to simultaneous invasive measurements.
Measured: For the duration of surgery
Differences in intraoperative hemodynamic measurements (stroke volume variation in %) between Task Force CORE compared with thermodilution during surgery
Intraoperative evaluation of the performance of Task Force variable stroke volume variation (in %) throughout surgery compared to simultaneous invasive measurements.
Measured: For the duration of surgery
Intraoperative continuous Cardioc Output measurements
The comparison of intraoperative continuous cardiac output measurements derived by the Task Force device with continuous invasive cardiac output measurements derived by the PiCCO throughout surgery or before, during and after clinically indicated interventions (e.g. medication, passive leg raising, fluid challenge).
Measured: For the duration of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic MeasurementStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Graz
- Responsible party
- Principal investigator, Christian Reiterer, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007196
- Sponsor's protocol ID
- Task_Force_01
- Status last verified
- Aug 2023
- First submitted
- 7 Jul 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of Non-invasive Continuous Hemodynamic Measurement From Task Force(R) CORE Versus Invasive Reference
- ClinicalTrials.gov ID
- NCT06007196
- Acronym / sponsor ID
- Task_Force_01
- Conditions
- Hemodynamic Measurement, Non-invasive, Cardiac Output
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Medical University of Graz
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 23 Aug 2023 (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.
Validation of hemodynamic measurements using the non-invasive Task Force Core(R) and Task Force Cardio(R) device with invasive hemodynamic measurements using the thermodilution technique (PICCO device).
Detailed description
The investigational device, Task Force® CORE (TFC, CNSystems Medizintechnik GmbH, Graz, Austria) together with the Task Force® CARDIO (TFCARDIO, CNSystems Medizintechnik GmbH, Graz, Austria) medical device software, is a new CE-marked medical device for continuous non-invasive determination of blood pressure (BP), cardiac output (CO) and derived parameters based on the well established CNAP® (continuous non-invasive arterial pressure) technology by CNSystems. The primary aim of this prospective, method comparison, open, multi-center study is data acquisition for the performance evaluation of the TFC in comparison with invasive reference methods (i.e. transpulmonary thermodilution, invasive blood pressure with radial artery catheter). The setting of the study will be the Operating Room (OR). This setting allows the comparison of the investigational device's cardiac output (CO) to invasive CO as well as of BP and derived hemodynamic parameters like Stroke Volume (SV), and Systemic Vascular Resistance (SVR). Measurements will be performed during the perioperative period, starting 15 minutes after the first skin incision.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous non-invasive Hemodynamic Monitoring | – | Device: non-invasive device (Task Force CORE(R) and Task Force CARDIO(R)Continuous non-invasive Hemodynamic Monitoring (Task Force CORE(R) and Task Force CARDIO(R)) will be compared to invasive thermodilution cardiac output measurements in all patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients, who undergo major abdominal surgery, which will require extended hemodynamic monitoring.
Key inclusion criteria (4 listed)
- Adult patients (patients aged at least 18 years)
- Patients undergoing major abdominal surgery who require invasive extended hemodynamic monitoring (trans pulmonary thermodilution via PiCCO and invasive blood pressure monitoring with radial artery catheter) according to clinical standard of care
- Patients with intact perfusion of both hands evidenced by a positive Allen's test
- Patients given written informed consent to participate in the study
Key exclusion criteria (7 listed)
- Patients with vascular impairments at the sites of non-invasive blood pressure measurement (fingers or upper arms)
- Patients with significant edema in the fingers
- Patients with ventricular assist devices or extracorporeal life-supporting devices
- Subjects not passing the Allen's test for both hands
- Patients who obtain vasoactive medications on the same arm as used for upper-arm Task Force blood pressure measurements
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 |
|---|---|---|
| non-invasive device (Task Force CORE(R) and Task Force CARDIO(R)Intraoperative cardiac output will be measured using the non-invasive device (Task Force CORE(R) and Task Force CARDIO(R) and will be compared with the invasive thermodilution method (PiCCO). | Device | Continuous non-invasive Hemodynamic Monitoring |
Primary outcome
Difference in intraoperative cardiac output measurements between Task Force CORE compared with thermodilution during surgery
Time frame: For the duration of surgery
Intraoperative performance of cardiac output values derived by the Task Force CORE system compared with cardiac output measurements derived by thermodilution measurements.
4 secondary outcomes
Differences in intraoperative hemodynamic measurements (blood pressure in mmHg) between Task Force CORE compared with thermodilution during surgery
Time frame: For the duration of surgery
Differences in intraoperative hemodynamic measurements (stroke volume in ml) between Task Force CORE compared with thermodilution during surgery
Time frame: For the duration of surgery
Differences in intraoperative hemodynamic measurements (stroke volume variation in %) between Task Force CORE compared with thermodilution during surgery
Time frame: For the duration of surgery
Intraoperative continuous Cardioc Output measurements
Time frame: For the duration of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
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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.
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 Hemodynamic Measurement and Non-invasive, run by Medical University of Vienna at 1 site in Austria.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 25 Aug 2023. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Reiterer, MD (+43 40400 ext. 20760, christian.reiterer@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in intraoperative cardiac output measurements between Task Force CORE compared with thermodilution during surgery (time frame: For the duration of surgery). 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 25 Aug 2023.