Non-invasive Blood Pressure Monitoring in Carotid Surgery (SPARK)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Carotid Endarterectomy Surgery

Treatments: Other: Continuous non-invasive blood pressure monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT06965257

APHP250362

2025-A00444-45 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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