Comparing Femoral and Radial Artery Pressure Monitoring in Adults Undergoing Elective Cardiac Surgery to Reduce Vasopressor Use
Led by Guillaume BESCH · Updated on 2025-12-22
340
Participants Needed
2
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
This research focuses on adults undergoing elective cardiac surgery with cardiopulmonary bypass. It compares two methods of invasive blood pressure monitoringfemoral artery versus radial artery catheterizationto see if femoral monitoring reduces the need for norepinephrine, a vasopressor, from anesthesia induction until seven days after surgery. The study addresses concerns that radial artery measurements may underestimate central arterial pressure, potentially leading to overtreatment and complications such as acute kidney injury and cardiac events. Current evidence is mainly observational and outdated, so this study aims to provide high-quality randomized data to guide clinical practices.
Participants are randomly assigned to one of two groups one receiving femoral artery catheterization and the other radial artery catheterization for continuous invasive blood pressure monitoring. The catheter is placed under ultrasound guidance in the operating room and remains in place postoperatively in the ICU until no longer needed. The study tracks patients from surgery through postoperative day seven to evaluate various outcomes related to vasopressor use, kidney and heart complications, arterial catheter-related issues, and length of hospital stay.
Throughout the study, researchers collect clinical data using electronic forms. They monitor norepinephrine use, episodes of low blood pressure during surgery, cardiac complications like arrhythmias and myocardial injury, kidney injury, and complications related to arterial catheters. Secondary outcomes include vasoactive-inotropic scores, duration and dose of vasopressor therapy, ICU and hospital stays, and mortality at seven and thirty days. The total participation lasts through the first week after surgery, aiming to clarify whether femoral artery monitoring improves patient outcomes and reduces drug use compared to radial artery monitoring.
CONDITIONS
Brief Title
Femoral Versus Radial Invasive Arterial Pressure Monitoring in Cardiac Surgery Patients
Research Team
G
Guillaume Besch, M.D., Ph.D.
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Scheduled for elective cardiac surgery with cardiopulmonary bypass
ASA physical status of II or higher
Affiliated with or beneficiary of the French national health insurance system
Signed informed consent indicating understanding of the study and agreement to participate
You will not qualify if you...
Emergency surgery before the next working day after decision to operate
Surgery requiring two arterial pressure monitoring sites (e.g., aortic arch surgery)
Heart transplantation surgery
Mechanical circulatory support
Contraindications to radial artery catheterization such as failed Allen test, Raynaud syndrome, Buerger disease, or major hyperlipidemia
Contraindications to femoral artery catheterization including vascular prosthetic material in the femoral area
Pregnant or breastfeeding women
Persons deprived of liberty by judicial or administrative decision or under compulsory psychiatric care
Adults under legal protection measures or unable to give informed consent
Currently under exclusion period of another clinical trial or listed in the national registry of research volunteers
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Surgery day
Participants undergo either femoral or radial artery catheterization for continuous invasive arterial blood pressure monitoring during cardiac surgery.
1 visit (in-person, during surgery)
Post-operative Follow-up
Duration - Up to 7 days after surgery
Participants are monitored for up to 7 days after surgery for vasopressor use, renal and cardiac complications, and catheter-related complications.
Daily visits or assessments for up to 7 days
Follow-up
Duration - Up to 30 days after surgery
Participants’ recovery is monitored including ICU and hospital length of stay and mortality up to 30 days after surgery.
Assessments as needed during ICU and hospital stay
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Published Research Related To This Trial
Femoral versus radial arterial pressure monitoring in cardiac surgery patients: protocol for a randomised controlled multicentric superiority trial (FERARI).
Pierre-Grégoire Guinot, Romain Bronnert, Tommy Grelet...