An observational study in Carotid Endarterectomy Surgery, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-03.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
Carotid endarterectomy surgery carries significant neurological and cardiac risks, requiring continuous monitoring of blood pressure. In standard practice, this monitoring is carried out using an arterial catheter inserted at the start of the operation. This invasive procedure is generally not well received by the patient and is a source of potential ischaemic and infectious complications.
The use of a non-invasive extracorporeal device (digital cuff) for continuous measurement of arterial pressure, based on detection of the pulse wave by plethysmography, could provide an interesting alternative. Nevertheless, the concordance of blood pressure curves measured continuously by the arterial catheter and by non-invasive pulse wave analysis remains insufficiently studied for carotid endarterectomy surgery.
The aim of this study was to evaluate the concordance, using the Bland-Altman method, of mean arterial pressure curves measured continuously by the invasive arterial catheter (standard management) and by non-invasive pulse wave contour analysis (non-invasive extracorporeal sensor) in carotid endarterectomy surgery.
This was a non-interventional study. Patient management is carried out according to current recommendations for carotid endarterectomy surgery: placement of an arterial catheter at the start of the procedure and frontal NIRS electrodes.
A non-invasive monitoring device (ClearSight™ digital cuff available on the investigation site) will then be added to measure blood pressure on the side ipsilateral to the arterial catheter.
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients undergoing carotid endarterectomy under general anaesthesia
Exclusion Criteria:
Addition prior to anaesthetic induction of the non-invasive monitoring device (digital sleeve available at the investigation site) for blood pressure measurement on the side ipsilateral to the arterial catheter
Bland-Altman concordance analysis (accuracy, reproducibility and limits of agreement) between mean arterial pressures measured invasively (arterial catheter) and non-invasively (extracorporeal sensor)
Concordance between mean arterial pressures measured by the invasive arterial catheter (standard management) and by a non-invasive extracorporeal sensor (study method) during the different phases of the care procedure
Time frame: through operative care procedure, [beginning of procedure ; end of procedure]
Bland-Altman concordance analyses (accuracy, reproducibility and limits of agreement) between systolic and diastolic arterial pressures measured invasively (arterial catheter) and non-invasively (extracorporeal sensor)
Measurement concordance for systolic and diastolic blood pressures
Time frame: through operative care procedure, [beginning of procedure ; end of procedure]
Focus on the successive phases of the procedure: anaesthetic induction, before, during and after carotid clamping
Concordance of measurements during the different phases of surgery (anaesthetic induction then before, during and after carotid clamping)
Time frame: through operative care procedure, [beginning of procedure ; end of procedure]
Invasive arterial pressure (measured in mmHg)
Relationship between invasive arterial pressure (measured in mmHg) and clinical parameters using regression model type y = f(x).
Time frame: through operative care procedure, [beginning of procedure ; end of procedure]
Non-invasive arterial pressure (measured in mmHg)
Relationship between non-invasive arterial pressure (measured in mmHg) and clinical parameters using regression model type y = f(x).
Time frame: through operative care procedure, [beginning of procedure ; end of procedure]
NIRS (measured in %)
Relationship between NIRS (measured in %) and clinical parameters using regression model type y = f(x).
Time frame: through operative care procedure, [beginning of procedure ; end of procedure]
Search for measurement bias according to operators using regression models
Identify any confounding variables (arrhythmias, operators)
Time frame: through operative care procedure, [beginning of procedure ; end of procedure]
Plan to share: No — DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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