Status:
RECRUITING
Femoral Versus Radial Invasive Arterial Pressure Monitoring in Cardiac Surgery Patients
Lead Sponsor:
Guillaume BESCH
Conditions:
Vasoplegia Syndrome
Vasoplegia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 f...
Detailed Description
Acute circulatory failure or shock-typically characterized by arterial hypotension-is a major cause of ICU admission and a significant contributor to postoperative complications in surgery. This condi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT06952907
Start Date
June 15 2025
End Date
August 1 2027
Last Update
December 22 2025
Active Locations (2)
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1
Centre Hospitalier Universitaire de Besançon
Besançon, France, F-25000
2
Centre Hospitalier Universitaire de Dijon
Dijon, France, F-21000