Coronary BypassNCT02692222
Measurement of Pulse Pressure Variation and Cardiac Output by a New Application for Android™ (Captesia™)
An observational study of Coronary Bypass, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
This study test the agreement and accuracy of Pulse Pressure Variation (PPV) and Cardiac Output (CO) obtained by the Android application Capstesia™ against the gold standard : PPV and CO calculated by thermodilution. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Bypass
- What is being tested?
- Calculation of PPV and CO with two methods
- How many people
- 57 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2016to Dec 2016
- 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: patients scheduled for coronary artery bypass
Who may be able to join
- patients scheduled for coronary artery bypass
Who cannot join
- patients with arrhythmias like atrial fibrillation
- patients with valvular insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measurement of Pulse Pressure Variation (PPV) and Cardiac Output (CO) by a New Application for Android™ (Captesia™) : Comparison With PPV and CO Obtained by a Method of Transpulmonary Thermodilution.
This study test the agreement and accuracy of Pulse Pressure Variation (PPV) and Cardiac Output (CO) obtained by the Android application Capstesia™ against the gold standard : PPV and CO calculated by thermodilution.
Read the detailed description
Pulse pressure variation (PPV) remains a good predictor of fluid responsiveness in the OR. However, PPV can be time-consuming to calculate (manual determination), is not always displayed on monitoring screens nor reliable through visual assessment and needs additional devices to be displayed. A new Android application (Captesia) automatically calculates the PPV utilizing a digital photograph of the arterial waveform from the monitor. The application determines the PPV by selecting peaks and troughs of the arterial curve.
- Conditions
- Coronary Bypass
- Being tested
- Calculation of PPV and CO with two methods
- Keywords
- pulse pressure variation monitoring, Captesia, cardiac output monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calculation of PPV and CO with two methodsOther
| Study group | Role | What they receive |
|---|---|---|
| PPV | This study will track changes in PPV and CO before and after of volume expansion, which goal is to change the cardiac output. Receives: Other: Calculation of PPV and CO with two methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
PPV
the Pulse Pressure Variation will be calculated by the Android Application (Captesia) and by the Picco before and after a meneuver of volume expansion, which goal is to change the cardiac output.
Measured: at time of surgery
Secondary outcomes (1)
CO
the Cardiac Output will be calculated by the Android Application (Captesia) and by thermodilution before and after of volume expansion, which goal is to change the cardiac output.
Measured: at time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2016
- Study completionDec 2016
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 Coronary BypassStudies 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
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Céline Boudart, Erasme University Hospital
- Investigators
- Céline F Boudart, MD, Principal investigator, Erasme Hospital BruxellesAlexandre Joosten, MD, Principal investigator, Erasme Hospital Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692222
- Sponsor's protocol ID
- B406201526827
- Status last verified
- Dec 2016
- First submitted
- 10 Feb 2016
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Yang X, Du B. Does pulse pressure variation predict fluid responsiveness in critically ill patients? A systematic review and meta-analysis. Crit Care. 2014 Nov 27;18(6):650. doi: 10.1186/s13054-014-0650-6.
PubMed 25427970Cannesson M, Le Manach Y, Hofer CK, Goarin JP, Lehot JJ, Vallet B, Tavernier B. Assessing the diagnostic accuracy of pulse pressure variations for the prediction of fluid responsiveness: a "gray zone" approach. Anesthesiology. 2011 Aug;115(2):231-41. doi: 10.1097/ALN.0b013e318225b80a.
PubMed 21705869
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Pulse Pressure Variation (PPV) and Cardiac Output (CO) by a New Application for Android™ (Captesia™) : Comparison With PPV and CO Obtained by a Method of Transpulmonary Thermodilution.
- ClinicalTrials.gov ID
- NCT02692222
- Acronym / sponsor ID
- B406201526827
- Conditions
- Coronary Bypass
- Keywords
- pulse pressure variation monitoring, Captesia, cardiac output monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Feb 2016 (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.
This study test the agreement and accuracy of Pulse Pressure Variation (PPV) and Cardiac Output (CO) obtained by the Android application Capstesia™ against the gold standard : PPV and CO calculated by thermodilution.
Detailed description
Pulse pressure variation (PPV) remains a good predictor of fluid responsiveness in the OR. However, PPV can be time-consuming to calculate (manual determination), is not always displayed on monitoring screens nor reliable through visual assessment and needs additional devices to be displayed. A new Android application (Captesia) automatically calculates the PPV utilizing a digital photograph of the arterial waveform from the monitor. The application determines the PPV by selecting peaks and troughs of the arterial curve.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PPV | – | Other: Calculation of PPV and CO with two methodsThis study will track changes in PPV and CO before and after of volume expansion, which goal is to change the cardiac output. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients scheduled for coronary artery bypass
Key inclusion criteria (1 listed)
- patients scheduled for coronary artery bypass
Key exclusion criteria (2 listed)
- patients with arrhythmias like atrial fibrillation
- patients with valvular insufficiency
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 |
|---|---|---|
| Calculation of PPV and CO with two methods | Other | PPV |
Primary outcome
PPV
Time frame: at time of surgery
the Pulse Pressure Variation will be calculated by the Android Application (Captesia) and by the Picco before and after a meneuver of volume expansion, which goal is to change the cardiac output.
1 secondary outcome
CO
Time frame: at time of surgery
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 7 Dec 2016.
- Background: PubMed 25427970Yang X, Du B. Does pulse pressure variation predict fluid responsiveness in critically ill patients? A systematic review and meta-analysis. Crit Care. 2014 Nov 27;18(6):650. doi: 10.1186/s13054-014-0650-6.
- Background: PubMed 21705869Cannesson M, Le Manach Y, Hofer CK, Goarin JP, Lehot JJ, Vallet B, Tavernier B. Assessing the diagnostic accuracy of pulse pressure variations for the prediction of fluid responsiveness: a "gray zone" approach. Anesthesiology. 2011 Aug;115(2):231-41. doi: 10.1097/ALN.0b013e318225b80a.
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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.
Céline F Boudart, MD principal investigator
Erasme Hospital Bruxelles
Alexandre Joosten, MD principal investigator
Erasme Hospital Bruxelles
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 Coronary Bypass, run by Erasme University Hospital at 1 site in Belgium.
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 2 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 7 Dec 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 Belgium. 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?
PPV (time frame: at time of surgery). 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 NCT02692222, 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 7 Dec 2016.