Cardiac Output, HighNCT02312505
Comparison of a New Semi-invasive Monitoring System With Transpulmonary Thermodilution in Cardiac Surgery Patients
A study testing COPFX in people with Cardiac Output, High, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
The aim of the study is to investigate the accuracy of a new semi-invasive cardiac output monitoring system in patients undergoing elective cardiac surgery. The investigators hypothesize that the semi-invasive device may be affected by mean arterial pressure and systemic vascular resistance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Output, High
- What is being tested?
- COPFX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2012to Dec 2014
- Phase
- Interventional
- 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
Who may be able to join
- Patients undergoing elective coronary artery bypass grafting Personal declaration of consent to the study
Who cannot join
- Patients <18 years of age A left ventricular ejection fraction ≤0.5 Emergency procedures Patients with haemodynamic instability requiring continuous pharmacologic support Patients with intracardiac shunts Severe aortic-, tricuspid- or mitral stenosis or insufficiency Mechanical circulatory support.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anaesthesiology and Intensive Care Medicine
Kiel, Schleswig-Holstein, 24105
About this study
Official title: Estimation of Cardiac Output by a New Semi-invasive Monitoring System: Accuracy and Limitations
The aim of the study is to investigate the accuracy of a new semi-invasive cardiac output monitoring system in patients undergoing elective cardiac surgery. The investigators hypothesize that the semi-invasive device may be affected by mean arterial pressure and systemic vascular resistance.
Read the detailed description
A recently introduced semi-invasive monitoring system consists of an algorithm that provides beat-to-beat measurement of CI by analysis of the arterial blood pressure tracing. By using the autocalibration mode this software calculates the individual aortic compliance and systemic vascular resistance by taking patient data like age, height, weight and gender into account. After estimation of beat-to-beat stroke volume, a subsequent multiplication by the heart rate delivers pulse contour cardiac index. Furthermore, this device offers the opportunity for external calibration by a reference technique, e.g. pulmonary or transpulmonary thermodilution.
The aim of the present study was to investigate the accuracy and trending ability of autocalibrated semi-invasive CI by a new arterial waveform analysis compared with transpulmonary thermodilution before and after cardiopulmonary bypass (CPB).
- Conditions
- Cardiac Output, High
- Being tested
- COPFX
- Keywords
- cardiac output monitoring, semi-invasive pulse contour analysis, transpulmonary thermodilution
- Medical subject headings
- Cardiac Output, High
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPFXDevice
cardiac Output by semi-invasive pulse contour analysis
| Study group | Role | What they receive |
|---|---|---|
| COPFX | Other | cardiac output by PulsioFlex® Monitoring system (COPFX) Receives: Device: COPFX |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac output by pulse contour Analysis compared with transpulmonary thermodilution
plotting cardiac output by a questionnaire, Statistics: correlation coefficients, Bland-Altman Analysis, trending ability by four Quadrant plots
Measured: participants will be followed for the start and the end of operation, on the average of 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startMar 2012
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Output, HighStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ole Broch, MD, University Hospital Schleswig-Holstein
- Investigators
- Berthold Bein, Professor, Study director, University Schleswig-Holstein, Campus Kiel, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312505
- Sponsor's protocol ID
- AZ 162/10
- Other IDs
- AZ 162/10
- Status last verified
- Oct 2016
- First submitted
- 3 Dec 2012
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Broch O, Carbonell J, Ferrando C, Metzner M, Carstens A, Albrecht M, Gruenewald M, Hocker J, Soro M, Steinfath M, Renner J, Bein B. Accuracy of an autocalibrated pulse contour analysis in cardiac surgery patients: a bi-center clinical trial. BMC Anesthesiol. 2015 Nov 26;15:171. doi: 10.1186/s12871-015-0153-2.
PubMed 26612072
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Cardiac Output by a New Semi-invasive Monitoring System: Accuracy and Limitations
- ClinicalTrials.gov ID
- NCT02312505
- Acronym / sponsor ID
- AZ 162/10
- Conditions
- Cardiac Output, High
- Keywords
- cardiac output monitoring, semi-invasive pulse contour analysis, transpulmonary thermodilution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Dec 2014 (estimated)
- 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.
The aim of the study is to investigate the accuracy of a new semi-invasive cardiac output monitoring system in patients undergoing elective cardiac surgery. The investigators hypothesize that the semi-invasive device may be affected by mean arterial pressure and systemic vascular resistance.
Detailed description
A recently introduced semi-invasive monitoring system consists of an algorithm that provides beat-to-beat measurement of CI by analysis of the arterial blood pressure tracing. By using the autocalibration mode this software calculates the individual aortic compliance and systemic vascular resistance by taking patient data like age, height, weight and gender into account. After estimation of beat-to-beat stroke volume, a subsequent multiplication by the heart rate delivers pulse contour cardiac index. Furthermore, this device offers the opportunity for external calibration by a reference technique, e.g. pulmonary or transpulmonary thermodilution.
The aim of the present study was to investigate the accuracy and trending ability of autocalibrated semi-invasive CI by a new arterial waveform analysis compared with transpulmonary thermodilution before and after cardiopulmonary bypass (CPB).
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPFX | Other | Device: COPFXcardiac output by PulsioFlex® Monitoring system (COPFX) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective coronary artery bypass grafting Personal declaration of consent to the study
Key exclusion criteria (1 listed)
- Patients <18 years of age A left ventricular ejection fraction ≤0.5 Emergency procedures Patients with haemodynamic instability requiring continuous pharmacologic support Patients with intracardiac shunts Severe aortic-, tricuspid- or mitral stenosis or insufficiency Mechanical circulatory support.
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 |
|---|---|---|
| COPFXcardiac Output by semi-invasive pulse contour analysis | Device | COPFX |
Primary outcome
cardiac output by pulse contour Analysis compared with transpulmonary thermodilution
Time frame: participants will be followed for the start and the end of operation, on the average of 4 hours
plotting cardiac output by a questionnaire, Statistics: correlation coefficients, Bland-Altman Analysis, trending ability by four Quadrant plots
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 25 Oct 2016.
- Derived from this study: PubMed 26612072Broch O, Carbonell J, Ferrando C, Metzner M, Carstens A, Albrecht M, Gruenewald M, Hocker J, Soro M, Steinfath M, Renner J, Bein B. Accuracy of an autocalibrated pulse contour analysis in cardiac surgery patients: a bi-center clinical trial. BMC Anesthesiol. 2015 Nov 26;15:171. doi: 10.1186/s12871-015-0153-2.
- Individual participant dataSharing planned: No
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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.
Berthold Bein, Professor study director
University Schleswig-Holstein, Campus Kiel, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COPFX in people with Cardiac Output, High, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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 1 inclusion and 1 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 25 Oct 2016. 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 Germany. 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 by pulse contour Analysis compared with transpulmonary thermodilution (time frame: participants will be followed for the start and the end of operation, on the average of 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02312505, which also lists 1 linked publication.
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 Oct 2016.