- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02652858
Central and Peripheral Arterial Pressure Decoupling In Cardio-Pulmonary Bypass (CAPD-CPB)
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bron, France, 69500
- Hospices Civils de Lyon
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Scheduled patient for coronary or valvular surgery with cardiopulmonary bypass
- Cardiopulmonary bypass is at least 90 minutes
- Written consent is needed
Exclusion Criteria:
- Patient with heart rate disorder
- Patient with aortic dissection
- Dobutamine/milrinone/levosimendan treatment before surgery
- Patient with heart rate due to a pacemaker
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pulse wave's speed observational arm
Whole patients for who the pulse wave's speed are measured during a cardiopulmonary bypass during cardiac surgery
|
Implementation of two additional NIBP on humeral and femoral sites.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Day one (6 times)
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General 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 record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 69HCL15_0400
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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