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Femoral versus radial arterial pressure monitoring in cardiac surgery patients: protocol for a randomised controlled multicentric superiority trial (FERARI)

Por: Guinot · P.-G. · Bronnert · R. · Grelet · T. · Bouhemad · B. · Nguyen · M. · Besch · G. · FERARI study group · Berthoud · Kabbout · Radhouani · Martin · Constandache · Durand · GrosJean · Bahr · Anciaux · Bernard · Morgant · Jazzayeri · Bernard · Ghalifa · Lubin · Nays · Guilhot · Al
Background

Accurate arterial pressure monitoring is critical in cardiac surgery to guide haemodynamic management and vasopressor therapy. Radial arterial pressure monitoring may systematically underestimate central aortic pressure compared with femoral monitoring, potentially leading to inappropriate vasopressor escalation and associated complications. Recent evidence demonstrates that excessive norepinephrine exposure is associated with acute kidney injury and increased mortality in cardiac surgery patients.

Objective

To determine whether femoral arterial pressure monitoring reduces norepinephrine use compared with radial monitoring in cardiac surgery patients.

Methods and analysis

This is a prospective, randomised, controlled, single-blind, superiority trial conducted at two French university hospitals (CHU Besancon and CHU Dijon). Adult patients undergoing cardiac surgery with cardiopulmonary bypass will be randomised 1:1 to receive either femoral or radial arterial pressure monitoring. The primary endpoint is the proportion of patients treated with norepinephrine from anaesthetic induction to postoperative day 7. Secondary endpoints include acute kidney injury according to KDIGO criteria, cardiac complications, vasoactive-inotropic scores, duration of vasopressor therapy, vascular complications, and 7-day and 30-day mortality. Sample size calculation indicates 340 patients (170 per group) are needed to detect a 15% absolute reduction in norepinephrine use with 90% power and α=0.05, and an anticipated loss to follow-up rate of 5%.

Ethics and dissemination

The study has been approved by the French Ethics Committee (Comité de Protection des Personnes Nord-Ouest II, no. 2024/897) and will be conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Results will be submitted for publication in peer-reviewed journals and presented at international conferences.

Trial registration number

NCT06952907.

Performance of artificial intelligence models for predicting intraoperative complications during surgery in real time: a systematic review and meta-analysis protocol

Por: Bronnert · R. · Besch · G. · Hild · O. · Lihoreau · T. · Chaussy · Y. · Ferreira · D.
Introduction

Intraoperative complications contribute significantly to morbidity and mortality, and reducing their risk is a primary objective for all operating room’s healthcare professionals. Many of these complications are predictable and could be anticipated by the surgeon or anaesthesiologist. Various clinical scores were developed to assess cardiovascular risk, acute kidney injury or acute respiratory failure preoperatively. However, these scores require time for calculation and are not designed to be adjusted in real time during surgery, based on physiological signals and new intraoperative events. Besides, some events remain unpredictable because they are multifactorial.

In recent decades, Artificial Intelligence (AI)-based algorithms have been tested for the real-time prediction of intraoperative complications. These algorithms have the potential to continuously analyse patient data and provide early warnings, enabling professionals to intervene more effectively.

The aim of this review is to address the question: ‘What is the performance of AI models in predicting intraoperative complications during surgery using baseline and real-time data?’.

Methods and analysis

The review will follow the Transparent Reporting of multivariable prediction models for Individual Prognosis or Diagnosis: Checklist for Systematic Reviews and Meta-Analyses and BMJ guidelines. MEDLINE, Embase, CENTRAL (Cochrane), IEEE Xplore and Google Scholar databases will be explored for peer-reviewed papers up to 25 March 2025. First, two reviewers will independently screen titles, abstracts and full texts based on the inclusion and exclusion criteria. A third reviewer will resolve any disagreements. Eligibility criteria include AI models that predict or forecast intraoperative complications or immediate postoperative complications (up to the stay in the Post-Anaesthesia Care Unit) involving any patient undergoing surgery or interventional procedures with general or locoregional anaesthesia. The primary target is the algorithm’s performance, depending on the choice of the authors. Key items from the CHARMS 2014 checklist will be extracted using a standardised form. Risk of bias assessment will be performed using the PROBAST+AI tool. If possible, meta-analysis will be conducted by implementing a random effects meta-analysis model.

Ethics and dissemination

Ethical approval is not required. The results will be published in a peer-reviewed journal and presented at national and international conferences.

Trial registration number

PROSPERO registration number: CRD420250599920. Any future amendments will be updated in the PROSPERO record.

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