Non-invasive Blood Pressure Monitoring in Carotid Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continuous non-invasive blood pressure monitoring.
- Who it may be relevant to
- Registry conditions: Carotid Endarterectomy Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Continuous Non-invasive Blood Pressure Monitoring During Carotid Endarterectomy Surgery
Overview
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.
Interventions
- Other Continuous non-invasive blood pressure monitoring
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
Primary outcome measures
- Bland-Altman concordance analysis (accuracy, reproducibility and limits of agreement) between mean arterial pressures measured invasively (arterial catheter) and non-invasively (extracorporeal sensor) [Time frame: through operative care procedure, [beginning of procedure ; end of procedure]]
Secondary outcome measures (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) [Time frame: 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 [Time frame: through operative care procedure, [beginning of procedure ; end of procedure]]
- Invasive arterial pressure (measured in mmHg) [Time frame: through operative care procedure, [beginning of procedure ; end of procedure]]
- Non-invasive arterial pressure (measured in mmHg) [Time frame: through operative care procedure, [beginning of procedure ; end of procedure]]
- NIRS (measured in %) [Time frame: through operative care procedure, [beginning of procedure ; end of procedure]]
- Search for measurement bias according to operators using regression models [Time frame: through operative care procedure, [beginning of procedure ; end of procedure]]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - DMU CARE — Créteil
Identifiers
NCT: NCT06965257 · APHP250362 · 2025-A00444-45