Non-invasive Blood Pressure Monitoring in Carotid Surgery

NCT06965257 | Recruiting

• 2 other identifiers: APHP2503622025-A00444-45
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Endarterectomy Surgery

Keywords

Prospective study; Non-invasive blood pressure monitoring; Carotid endarterectomy surgery; Anaesthesia

Outcome Measures

Primary Outcomes (1)

• 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

  through operative care procedure, [beginning of procedure ; end of procedure]

Secondary Outcomes (6)

• 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]

• 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]

• Invasive arterial pressure (measured in mmHg)

  through operative care procedure, [beginning of procedure ; end of procedure]

• Non-invasive arterial pressure (measured in mmHg)

  through operative care procedure, [beginning of procedure ; end of procedure]

• NIRS (measured in %)

  through operative care procedure, [beginning of procedure ; end of procedure]

Interventions

Continuous non-invasive blood pressure monitoring OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients undergoing carotid endarterectomy under general anaesthesia

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - DMU CARE

Créteil, France, 94000, France

RECRUITING

Central Study Contacts

Nicolas Bertrand, MD

CONTACT

(+33) 0149835907; nicolas.bertrand@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: May 11, 2025
• Study Start: May 1, 2026
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)