Carotid Endarterectomy SurgerySPARKNCT06965257
Non-invasive Blood Pressure Monitoring in Carotid Surgery
An observational study of Carotid Endarterectomy Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Endarterectomy Surgery
- What is being tested?
- Continuous non-invasive blood pressure monitoring
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- May 2026to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing carotid endarterectomy under general anaesthesia
Who may be able to join
- Patients over 18 years of age
- Patients undergoing carotid endarterectomy surgery under general anesthetic
- Patient who has been informed and has not objected
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - DMU CARE
Créteil, France, 94000
Nicolas Bertrand, MD, (+33) 0149835907, nicolas.bertrand@aphp.fr
About this study
Official title: 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.
Read more
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.
- Conditions
- Carotid Endarterectomy Surgery
- Being tested
- Continuous non-invasive blood pressure monitoring
- Keywords
- Prospective study, Non-invasive blood pressure monitoring, Carotid endarterectomy surgery, Anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous non-invasive blood pressure monitoringOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Bland-Altman concordance analysis (accuracy, reproducibility and limits of agreement) between mean arterial pressures measured invasively (arterial catheter) and non-invasively (extracorporeal sensor)
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
Measured: through operative care procedure, [beginning of procedure ; end of procedure]
Secondary outcomes (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)
Measurement concordance for systolic and diastolic blood pressures
Measured: 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
Concordance of measurements during the different phases of surgery (anaesthetic induction then before, during and after carotid clamping)
Measured: through operative care procedure, [beginning of procedure ; end of procedure]
Invasive arterial pressure (measured in mmHg)
Relationship between invasive arterial pressure (measured in mmHg) and clinical parameters using regression model type y = f(x).
Measured: through operative care procedure, [beginning of procedure ; end of procedure]
Non-invasive arterial pressure (measured in mmHg)
Relationship between non-invasive arterial pressure (measured in mmHg) and clinical parameters using regression model type y = f(x).
Measured: through operative care procedure, [beginning of procedure ; end of procedure]
NIRS (measured in %)
Relationship between NIRS (measured in %) and clinical parameters using regression model type y = f(x).
Measured: through operative care procedure, [beginning of procedure ; end of procedure]
Search for measurement bias according to operators using regression models
Identify any confounding variables (arrhythmias, operators)
Measured: through operative care procedure, [beginning of procedure ; end of procedure]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study startMay 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Endarterectomy SurgeryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965257
- Sponsor's protocol ID
- APHP250362
- Other IDs
- 2025-A00444-45
- Acronym
- SPARK
- Status last verified
- Sep 2025
- First submitted
- 14 Apr 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Non-invasive Blood Pressure Monitoring During Carotid Endarterectomy Surgery
- ClinicalTrials.gov ID
- NCT06965257
- Acronym / sponsor ID
- SPARK / APHP250362
- Conditions
- Carotid Endarterectomy Surgery
- Keywords
- Prospective study, Non-invasive blood pressure monitoring, Carotid endarterectomy surgery, Anaesthesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing carotid endarterectomy under general anaesthesia
Key inclusion criteria (3 listed)
- Patients over 18 years of age
- Patients undergoing carotid endarterectomy surgery under general anesthetic
- Patient who has been informed and has not objected
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous non-invasive blood pressure monitoringAddition 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 | Other | – |
Primary outcome
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
6 secondary outcomes
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]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No. DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Endarterectomy Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Bertrand, MD ((+33) 0149835907, nicolas.bertrand@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.