Central and Peripheral Arterial Pressure Decoupling In Cardio-Pulmonary Bypass

NCT02652858 | Completed

• 1 other identifier: 69HCL15_0400
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiopulmonary Bypass; Cardiac Surgery; Extracorporeal Circulation

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

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

Procedure: Non-invasive blood pressure oscillometer (NIBP) implementation

Interventions

Non-invasive blood pressure oscillometer (NIBP) implementation PROCEDURE

Implementation of two additional NIBP on humeral and femoral sites.

Pulse wave's speed observational arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled patient for coronary or valvular surgery with cardiopulmonary bypass
• Cardiopulmonary bypass is at least 90 minutes
• Written consent is needed

You may not qualify if:

• Patient with heart rate disorder
• Patient with aortic dissection
• Dobutamine/milrinone/levosimendan treatment before surgery
• Patient with heart rate due to a pacemaker

Sponsors & Collaborators

• Hospices Civils de Lyon: lead
• Université Joseph Fournier Grenoble 1: collaborator

Study Sites (1)

Hospices Civils de Lyon

Bron, 69500, France

Location

Related Publications (1)

• 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.

  BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 12, 2016
• Study Start: January 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

FR (1)