Non-invasive Blood Pressure Monitoring in Carotid Surgery

Recruiting now

Conditions studied: Carotid Endarterectomy Surgery

In brief

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.

Key facts

Study ID

NCT06965257

Run by

Assistance Publique - Hôpitaux de Paris

People needed

40

Starts

2026-05-01

Expected to finish

2026-05-01

Last updated by the study team

2025-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients over 18 years of age
• Patients undergoing carotid endarterectomy surgery under general anesthetic
• Patient who has been informed and has not objected

You may not qualify if…

• Technical or physical impossibility of inserting an arterial catheter or extracorporeal sensor (digital cuff)
• Patient of legal age unable to express his/her opposition
• Patient under guardianship, curatorship or legal protection
• Patient deprived of liberty

Where it is running

• Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - DMU CARE — Créteil, France, France (enrolling)

Full record on ClinicalTrials.gov

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