Non-invasive Blood Pressure Monitoring in Carotid Surgery (SPARK)

September 30, 2025 updated by: Assistance Publique - Hôpitaux de Paris

Continuous Non-invasive Blood Pressure Monitoring During Carotid Endarterectomy Surgery

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • France
      • Créteil, France, France, 94000
        • Recruiting
        • Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - DMU CARE
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients undergoing carotid endarterectomy under general anaesthesia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
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
through operative care procedure, [beginning of procedure ; end of procedure]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
Measurement concordance for systolic and diastolic blood pressures
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]
Concordance of measurements during the different phases of surgery (anaesthetic induction then before, during and after carotid clamping)
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]
Relationship between invasive arterial pressure (measured in mmHg) and clinical parameters using regression model type y = f(x).
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]
Relationship between non-invasive arterial pressure (measured in mmHg) and clinical parameters using regression model type y = f(x).
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]
Relationship between NIRS (measured in %) and clinical parameters using regression model type y = f(x).
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]
Identify any confounding variables (arrhythmias, operators)
through operative care procedure, [beginning of procedure ; end of procedure]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

April 14, 2025

First Submitted That Met QC Criteria

May 7, 2025

First Posted (Actual)

May 11, 2025

Study Record Updates

Last Update Posted (Estimated)

October 3, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • APHP250362
  • 2025-A00444-45 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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