Clinical trial NCT06965257: Non-invasive Blood Pressure Monitoring in Carotid Surgery
Official title: Continuous Non-invasive Blood Pressure Monitoring During Carotid Endarterectomy Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Carotid Endarterectomy Surgery
Keywords: Prospective study
Non-invasive blood pressure monitoring
Carotid endarterectomy surgery
Anaesthesia
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing carotid endarterectomy under general anaesthesia

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.


Eligibility criteria: 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

Primary outcomes:
measure: Bland-Altman concordance analysis (accuracy, reproducibility and limits of agreement) between mean arterial pressures measured invasively (arterial catheter) and non-invasively (extracorporeal sensor)
timeFrame: through operative care procedure, [beginning of procedure ; end of procedure]
Secondary outcomes:
measure: 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)
timeFrame: through operative care procedure, [beginning of procedure ; end of procedure]
measure: Focus on the successive phases of the procedure: anaesthetic induction, before, during and after carotid clamping
timeFrame: through operative care procedure, [beginning of procedure ; end of procedure]
measure: Invasive arterial pressure (measured in mmHg)
timeFrame: through operative care procedure, [beginning of procedure ; end of procedure]
measure: Non-invasive arterial pressure (measured in mmHg)
timeFrame: through operative care procedure, [beginning of procedure ; end of procedure]
measure: NIRS (measured in %)
timeFrame: through operative care procedure, [beginning of procedure ; end of procedure]
measure: Search for measurement bias according to operators using regression models
timeFrame: through operative care procedure, [beginning of procedure ; end of procedure]
Other outcomes:
Locations:
city: Créteil
country: France
facility: Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - DMU CARE
Study officials:
References: