Cardiopulmonary BypassCAPD-CPBNCT02652858
Central and Peripheral Arterial Pressure Decoupling In Cardio-Pulmonary Bypass
A study testing Non-invasive blood pressure oscillometer (NIBP) implementation in people with Cardiopulmonary Bypass and Cardiac Surgery, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Central and peripheral arterial pressure decoupling occurs in some clinical conditions like sepsis or cardiopulmonary bypass. This decoupling may leed to unsuitable decisions such as the use of catecholamines. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiopulmonary Bypass, Cardiac Surgery, Extracorporeal Circulation
- What is being tested?
- Non-invasive blood pressure oscillometer (NIBP) implementation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to Sep 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled patient for coronary or valvular surgery with cardiopulmonary bypass
- Cardiopulmonary bypass is at least 90 minutes
- Written consent is needed
Who cannot join
- Patient with heart rate disorder
- Patient with aortic dissection
- Dobutamine/milrinone/levosimendan treatment before surgery
- Patient with heart rate due to a pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Central and peripheral arterial pressure decoupling occurs in some clinical conditions like sepsis or cardiopulmonary bypass. This decoupling may leed to unsuitable decisions such as the use of catecholamines.
The aim of this study is to evaluate the pulse wave's speed as a marker of central and peripheral arterial pressure decoupling in a scheduled condition which is the cardiopulmonary bypass during cardiac surgery.
- Being tested
- Non-invasive blood pressure oscillometer (NIBP) implementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive blood pressure oscillometer (NIBP) implementationProcedure or surgery
Implementation of two additional NIBP on humeral and femoral sites.
| Study group | Role | What they receive |
|---|---|---|
| Pulse wave's speed observational arm | Experimental | Whole patients for who the pulse wave's speed are measured during a cardiopulmonary bypass during cardiac surgery Receives: Procedure: Non-invasive blood pressure oscillometer (NIBP) implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of femoral, radial and humeral pulses during a cardiopulmonary by-pass (CPBP).
Pulse wave's speed is calculated using 1) time between ECG R-wave and local detection of the pulse wave (femoral, humeral and radial) 2) a length from heart to these sites.
Wave detection at femoral and humeral sites will use oscillometry and wave detection at radial site will use an invasive catheter which is always set for this surgery.
Measured: Day one (6 times)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2016
- Study completionSep 2016
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 Cardiopulmonary BypassStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Université Joseph Fournier Grenoble 1
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652858
- Sponsor's protocol ID
- 69HCL15_0400
- Acronym
- CAPD-CPB
- Status last verified
- Sep 2025
- First submitted
- 6 Jan 2016
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
N. Smal, L. Guigue, D. Anglade, C. Lavault, F. Grimbert, Y. Lavault, F. Boucher, J.L. Fellahi. Assessment of central-peripheral arterial pressure decoupling: a preliminary study in cardiac surgery under cardiopulmonary bypass (CPB). Abstract presented at the Annual Congress of the French Society of Anaesthesia and Intensive Care (SFAR), Paris, 2017.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central and Peripheral Arterial Pressure Decoupling In Cardio-Pulmonary Bypass
- ClinicalTrials.gov ID
- NCT02652858
- Acronym / sponsor ID
- CAPD-CPB / 69HCL15_0400
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- Université Joseph Fournier Grenoble 1
- Study start
- Jan 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 12 Jan 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.
Central and peripheral arterial pressure decoupling occurs in some clinical conditions like sepsis or cardiopulmonary bypass. This decoupling may leed to unsuitable decisions such as the use of catecholamines.
The aim of this study is to evaluate the pulse wave's speed as a marker of central and peripheral arterial pressure decoupling in a scheduled condition which is the cardiopulmonary bypass during cardiac surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulse wave's speed observational arm | Experimental | Procedure: Non-invasive blood pressure oscillometer (NIBP) implementationWhole patients for who the pulse wave's speed are measured during a cardiopulmonary bypass during cardiac surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled patient for coronary or valvular surgery with cardiopulmonary bypass
- Cardiopulmonary bypass is at least 90 minutes
- Written consent is needed
Key exclusion criteria (4 listed)
- Patient with heart rate disorder
- Patient with aortic dissection
- Dobutamine/milrinone/levosimendan treatment before surgery
- Patient with heart rate due to a pacemaker
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 blood pressure oscillometer (NIBP) implementationImplementation of two additional NIBP on humeral and femoral sites. | Procedure or surgery | Pulse wave's speed observational arm |
Primary outcome
Measurement of femoral, radial and humeral pulses during a cardiopulmonary by-pass (CPBP).
Time frame: Day one (6 times)
Pulse wave's speed is calculated using 1) time between ECG R-wave and local detection of the pulse wave (femoral, humeral and radial) 2) a length from heart to these sites. Wave detection at femoral and humeral sites will use oscillometry and wave detection at radial site will use an invasive catheter which is always set for this 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 9 Sep 2025.
- Results publicationN. Smal, L. Guigue, D. Anglade, C. Lavault, F. Grimbert, Y. Lavault, F. Boucher, J.L. Fellahi. Assessment of central-peripheral arterial pressure decoupling: a preliminary study in cardiac surgery under cardiopulmonary bypass (CPB). Abstract presented at the Annual Congress of the French Society of Anaesthesia and Intensive Care (SFAR), Paris, 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive blood pressure oscillometer (NIBP) implementation in people with Cardiopulmonary Bypass and Cardiac Surgery, run by Hospices Civils de Lyon at 1 site in France.
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 9 Sep 2025. 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 France. 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?
Measurement of femoral, radial and humeral pulses during a cardiopulmonary by-pass (CPBP). (time frame: Day one (6 times)). 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 NCT02652858, 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 9 Sep 2025.