Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - DMU CARE
Créteil, France, 94000
Location status: Recruiting
NCT Number: NCT06965257
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Créteil, France, 94000
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 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
Time frame: through operative care procedure, [beginning of procedure ; end of procedure]
Measurement concordance for systolic and diastolic blood pressures
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: through operative care procedure, [beginning of procedure ; end of procedure]
Identify any confounding variables (arrhythmias, operators)
Contact information is provided by the study sponsor or research team.
Assistance Publique - Hôpitaux de Paris
Other
Continuous Non-invasive Blood Pressure Monitoring During Carotid Endarterectomy Surgery
Acronym: SPARK
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