Femoral versus radial arterial pressure monitoring during cardiac surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this interventional protocol adult patients scheduled for elective cardiac surgery with cardiopulmonary bypass will receive either femoral or radial arterial catheterization for continuous invasive blood pressure monitoring and the readings will be compared. The study compares central (femoral) versus peripheral (radial) arterial pressure signals during and after surgery and examines impacts on vasopressor dosing and hemodynamic management. The rationale is that radial measurements can underestimate central pressure in patients on vasopressors, potentially leading to overtreatment. The trial is conducted at two French university hospitals and enrolls consenting adults covered by the French national health insurance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male and female patients ≥18 years
* Scheduled cardiac surgery with cardiopulmonary bypass (time between anesthesia consultation and surgery \> 48 hours)
* ASA physical status ≥II
* Affiliation with or beneficiary of the French national health insurance system
* Signed informed consent indicating that the participant has understood the purpose and procedures of the study and agrees to participate and comply with its requirements and restrictions

Exclusion Criteria:

* Emergency surgery (before the next working day after decision to operate)
* Surgery requiring the use of two arterial pressure monitoring sites: e.g., aortic arch surgery, aortic dissection, etc.
* Heart transplantation surgery
* Mechanical circulatory support
* Contraindication to radial artery catheterization: failed Allen test, Raynaud syndrome, Buerger disease, major hyperlipidemia
* Contraindication to femoral artery catheterization: puncture of vascular prosthetic material in the femoral area (e.g., femoral bypass, femoral stenting, femoral trifurcation endarterectomy, femoral angioplasty)
* Pregnant or breastfeeding women
* Persons deprived of liberty by judicial or administrative decision; persons under compulsory psychiatric care; persons admitted to a healthcare or social institution for reasons other than research
* Adults under legal protection measures (guardianship, trusteeship, or legal safeguard) or unable to give informed consent
* Subjects currently under exclusion period of another clinical trial or listed in the national registry of research volunteers

Where it's running

• Centre Hospitalier Universitaire de Besançon
  Besançon, France Recruiting
• Centre Hospitalier Universitaire de Dijon
  Dijon, France Recruiting

Study contacts

• Principal investigator: Guillaume Besch, M.D., Ph.D. — Centre Hospitalier Universitaire de Besancon
• Study coordinator: Guillaume Besch, M.D., Ph.D.
• Email: gbesch@chu-besancon.fr
• Phone: +333 812 189 58

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.