Actively Recruiting

Age: 18Years +
All Genders
NCT06965257

Non-invasive Blood Pressure Monitoring in Carotid Surgery

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-10-03

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Non-invasive Blood Pressure Monitoring in Carotid Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

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

Créteil, France, France, 94000

Actively Recruiting

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Research Team

N

Nicolas Bertrand, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Non-invasive Blood Pressure Monitoring in Carotid Surgery | DecenTrialz