Carotid Endarterectomy Surgery
Conditions
Keywords
Prospective study, Non-invasive blood pressure monitoring, Carotid endarterectomy surgery, 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.
Interventions
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
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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 |
| 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) |
| 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). |
Countries
France
Contacts
Primary ContactNicolas Bertrand, MD
Outcome results
None listed