Cardiovascular DiseaseNCT02382120
Accuracy of Non-invasive Effective Pulmonary Perfusion Measurement by CO2
An observational study of Cardiovascular Disease, run by Hospital Privado de Comunidad de Mar del Plata at 1 site in Argentina.
Trial summary
Cardiac output monitoring is mandatory in most surgical and critical care patients. Many techniques to assess cardiac output are invasive and/or have many limitations, contraindications and drawbacks. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Cardiovascular Disease
- How many people
- 30 participants
- Where
- 1 siteArgentina
- Study dates
- 2 Mar 2015to 21 Jul 2018
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiac surgical ASA II-III patients.
Who may be able to join
- Written informed consent
- Programmed cardiac surgeries
- Surgeries with cardiopulmonary bypass
Who cannot join
- Emergency surgeries.
- Acute pulmonary diseases
- Contraindication of femoral catheters.
- Need of counter-pulsation baloon
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Privado de Comunidad
Mar del Plata, Buenos Aires, 7600
About this study
Official title: Accuracy and Precision of Non-invasive Effective Pulmonary Perfusion Measurement Using Volumetric Capnography
Cardiac output monitoring is mandatory in most surgical and critical care patients. Many techniques to assess cardiac output are invasive and/or have many limitations, contraindications and drawbacks. The measurement of cardiac output throughout the CO2 signal is an interesting option due to the simplicity and non-invasive nature of its calculation.
The present study was designed to compare the cardiac output measurement using a capnodynamic formula versus the reference thermodilution method.
Read the detailed description
This is a prospective and observational study designed to test the accuracy and precision of the non-invasive capnodynamic cardiac output measurement in mechanically ventilated patients. We will study 30 patients undergoing cardiovascular by pass in which an invasive trans-thoracic thermodilution method (PICCOScience) is indicated - the reference method.
A pair of thermodilutions and capnodynamic cardiac output measurement will be performed along the surgery. Analysis of precision will be done at the begining of the protocol and during stable hemodynamic conditions. Accuracy will then assessed using the Bland-Altmann plot and regression analysis.
- Conditions
- Cardiovascular Disease
- Keywords
- carbon dioxide, cardiac output, ventilation, thermodilution
- Medical subject headings
- Cardiovascular Diseases, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing cardiovascular surgery | Patients ASA 3-4 undergoing cardiac surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy and precision of capnodynamic to measure cardiac output
Comparison between a reference method (thermodilution) with a new one (capnodynamics)
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study start2 Mar 2015
- Primary completion21 Apr 2018
- Study completion21 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Privado de Comunidad de Mar del Plata
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerardo Tusman, MD, Principal investigator, Hospital Privado de Comunidad de Mar del Plata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382120
- Sponsor's protocol ID
- 23022015
- Status last verified
- May 2018
- First submitted
- 3 Mar 2015
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Capek JM, Roy RJ. Noninvasive measurement of cardiac output using partial CO2 rebreathing. IEEE Trans Biomed Eng. 1988 Sep;35(9):653-61. doi: 10.1109/10.7266. No abstract available.
PubMed 3139547Peyton PJ, Venkatesan Y, Hood SG, Junor P, May C. Noninvasive, automated and continuous cardiac output monitoring by pulmonary capnodynamics: breath-by-breath comparison with ultrasonic flow probe. Anesthesiology. 2006 Jul;105(1):72-80. doi: 10.1097/00000542-200607000-00015.
PubMed 16809997
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy and Precision of Non-invasive Effective Pulmonary Perfusion Measurement Using Volumetric Capnography
- ClinicalTrials.gov ID
- NCT02382120
- Acronym / sponsor ID
- 23022015
- Conditions
- Cardiovascular Disease
- Keywords
- carbon dioxide, cardiac output, ventilation, thermodilution
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital Privado de Comunidad de Mar del PlataUniversity, hospital or other
- Study start
- 2 Mar 2015 (actual)
- Primary completion
- 21 Apr 2018 (actual)
- Study completion
- 21 Jul 2018 (actual)
- First posted
- 6 Mar 2015 (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.
Cardiac output monitoring is mandatory in most surgical and critical care patients. Many techniques to assess cardiac output are invasive and/or have many limitations, contraindications and drawbacks. The measurement of cardiac output throughout the CO2 signal is an interesting option due to the simplicity and non-invasive nature of its calculation.
The present study was designed to compare the cardiac output measurement using a capnodynamic formula versus the reference thermodilution method.
Detailed description
This is a prospective and observational study designed to test the accuracy and precision of the non-invasive capnodynamic cardiac output measurement in mechanically ventilated patients. We will study 30 patients undergoing cardiovascular by pass in which an invasive trans-thoracic thermodilution method (PICCOScience) is indicated - the reference method.
A pair of thermodilutions and capnodynamic cardiac output measurement will be performed along the surgery. Analysis of precision will be done at the begining of the protocol and during stable hemodynamic conditions. Accuracy will then assessed using the Bland-Altmann plot and regression analysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing cardiovascular surgery | – | –Patients ASA 3-4 undergoing cardiac surgery. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac surgical ASA II-III patients.
Key inclusion criteria (3 listed)
- Written informed consent
- Programmed cardiac surgeries
- Surgeries with cardiopulmonary bypass
Key exclusion criteria (4 listed)
- Emergency surgeries.
- Acute pulmonary diseases
- Contraindication of femoral catheters.
- Need of counter-pulsation baloon
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy and precision of capnodynamic to measure cardiac output
Time frame: 8 months
Comparison between a reference method (thermodilution) with a new one (capnodynamics)
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 2 Aug 2018.
- Background: PubMed 3139547Capek JM, Roy RJ. Noninvasive measurement of cardiac output using partial CO2 rebreathing. IEEE Trans Biomed Eng. 1988 Sep;35(9):653-61. doi: 10.1109/10.7266. No abstract available.
- Results publication: PubMed 16809997Peyton PJ, Venkatesan Y, Hood SG, Junor P, May C. Noninvasive, automated and continuous cardiac output monitoring by pulmonary capnodynamics: breath-by-breath comparison with ultrasonic flow probe. Anesthesiology. 2006 Jul;105(1):72-80. doi: 10.1097/00000542-200607000-00015.
- 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.
Gerardo Tusman, MD principal investigator
Hospital Privado de Comunidad de Mar del Plata
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 Cardiovascular Disease, run by Hospital Privado de Comunidad de Mar del Plata at 1 site in Argentina.
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 4 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 2 Aug 2018. 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 Argentina. 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?
Accuracy and precision of capnodynamic to measure cardiac output (time frame: 8 months). 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 NCT02382120, which also lists 2 linked publications.
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 2 Aug 2018.