Non-invasive Blood Pressure Monitoring in Carotid Surgery

Not yet recruiting

• Conditions: Carotid Endarterectomy Surgery

• Registration Number: NCT06965257
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-14
• Study First Submitted QC: 2025-05-07
• Last Update Submitted: 2025-05-07
• Study First Posted: 2025-05-11
• Last Update Posted: 2025-05-11
• Study Start: 2026-05
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bland-Altman concordance analysis (accuracy, reproducibility and limits of agreement) between mean arterial pressures measured invasively (arterial catheter) and non-invasively (extracorporeal sensor)	through operative care procedure, [beginning of procedure ; end of procedure]	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

Secondary Outcome Measures

Name	Time	Method
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)	through operative care procedure, [beginning of procedure ; end of procedure]	Measurement concordance for systolic and diastolic blood pressures
Focus on the successive phases of the procedure: anaesthetic induction, before, during and after carotid clamping	through operative care procedure, [beginning of procedure ; end of procedure]	Concordance of measurements during the different phases of surgery (anaesthetic induction then before, during and after carotid clamping)
Invasive arterial pressure (measured in mmHg)	through operative care procedure, [beginning of procedure ; end of procedure]	Relationship between invasive arterial pressure (measured in mmHg) and clinical parameters using regression model type y = f(x).
Non-invasive arterial pressure (measured in mmHg)	through operative care procedure, [beginning of procedure ; end of procedure]	Relationship between non-invasive arterial pressure (measured in mmHg) and clinical parameters using regression model type y = f(x).
NIRS (measured in %)	through operative care procedure, [beginning of procedure ; end of procedure]	Relationship between NIRS (measured in %) and clinical parameters using regression model type y = f(x).
Search for measurement bias according to operators using regression models	through operative care procedure, [beginning of procedure ; end of procedure]	Identify any confounding variables (arrhythmias, operators)

Trial Locations

Locations (1)

Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - DMU CARE; 🇫🇷 Créteil, France