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NCT Number: NCT06965257

Non-invasive Blood Pressure Monitoring in Carotid 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - DMU CARE

Créteil, France, 94000

Location status: Recruiting

Location contact

Nicolas Bertrand, MD

CONTACT

[email protected]

(+33) 0149835907

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous non-invasive blood pressure monitoring

Other

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 outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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)

  3. 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).

  4. 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).

  5. 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).

  6. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Nicolas Bertrand, MD

CONTACT

[email protected]

(+33) 0149835907

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Continuous Non-invasive Blood Pressure Monitoring During Carotid Endarterectomy Surgery

Acronym: SPARK

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 11, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.