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Femoral Versus Radial Invasive Arterial Pressure Monitoring in Cardiac Surgery Patients

RecruitingNAAges 18 Years - anyAllGuillaume BESCH
NCT06952907 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background: Acute circulatory failure, often presenting as arterial hypotension, is a major contributor to postoperative morbidity and mortality. Accurate blood pressure (BP) monitoring is essential for timely therapeutic intervention, particularly in patients undergoing major surgery. Among invasive BP measurement sites, the radial artery is commonly used due to its accessibility and ease of catheterization. However, physiologically, the radial artery may underestimate central arterial pressure compared to the femoral artery, especially in patients receiving vasopressors or in critical conditions. This discrepancy can lead to overtreatment with vasopressors and associated complications. Current literature on the accuracy of radial versus femoral BP monitoring is outdated and based solely on observational studies. There is a lack of high-quality randomized data to inform clinical guideli

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📋 Eligibility rules (as published)
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
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What it tests

  • Femoral artery catheterization for continuous invasive arterial blood pressure monitoring
  • Radial artery catheterization for continuous invasive arterial blood pressure monitoring
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Where

2 sites
Centre Hospitalier Universitaire de Besançon
Besançon, France
Centre Hospitalier Universitaire de Dijon
Dijon, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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