Central and Peripheral Arterial Pressure Decoupling In Cardio-Pulmonary Bypass (CAPD-CPB)

September 2, 2025 updated by: Hospices Civils de Lyon

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bron, France, 69500
        • Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

January 6, 2016

First Submitted That Met QC Criteria

January 8, 2016

First Posted (Estimated)

January 12, 2016

Study Record Updates

Last Update Posted (Estimated)

September 9, 2025

Last Update Submitted That Met QC Criteria

September 2, 2025

Last Verified

September 1, 2025

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)?

UNDECIDED

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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