Central and Peripheral Arterial Pressure Decoupling In Cardio-Pulmonary Bypass

Cardiac Surgery Clinical Trial

— CAPD-CPB  

Official title:

Central and Peripheral Arterial Pressure Decoupling In Cardio-Pulmonary Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02652858
• Other study ID #: 69HCL15_0400
• Status: Completed
• Phase: N/A
• First received: January 6, 2016
• Last updated: October 7, 2016
• Start date: January 2016
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cardiac Surgery
• Cardiopulmonary Bypass
• Extracorporeal Circulation

Intervention

Procedure:
• Non-invasive blood pressure oscillometer (NIBP) implementation
Implementation of two additional NIBP on humeral and femoral sites.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Bron

Sponsors (2)

Lead Sponsor	Collaborator
Hospices Civils de Lyon	Université Joseph Fournier Grenoble 1

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day one (6 times)	Yes