Non-invasive continuous blood pressure monitoring during carotid endarterectomy
Official title: Continuous Non-invasive Blood Pressure Monitoring During Carotid Endarterectomy Surgery
Run by Assistance Publique - Hôpitaux de Paris · NCT06965257 · Data updated 2026-11-12
This test will see if a non-invasive digital cuff can continuously track blood pressure as accurately as an arterial catheter in adults having carotid endarterectomy under general anesthesia.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Créteil, France) |
| Status | Recruiting |
| Started | May 2026 |
| Main results expected | May 2026 |
| Study ends | May 2026 |
| Registry record updated | October 3, 2025 |
| Trial ID | NCT06965257 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) scheduled for carotid endarterectomy under general anesthesia who can give consent and for whom both an arterial catheter and the digital cuff can be applied.
✕Probably not a fit
Patients who cannot have an arterial catheter or a digital cuff placed, those unable to express consent, or those under guardianship or deprived of liberty are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational study compares continuous arterial pressure curves from the standard invasive arterial catheter with readings from a non-invasive digital cuff using plethysmography during carotid endarterectomy. Continuous blood pressure will be recorded from both devices throughout the operation and agreement between methods will be analyzed using Bland–Altman comparisons of mean arterial pressure curves. The aim is to characterize concordance and to identify situations where the non-invasive device performs reliably or diverges from the arterial line. The single-center study is conducted at CHU Henri Mondor and enrolls adult patients who can consent and for whom both monitoring methods can be placed.
Why it matters
Potential benefit: If successful, the non-invasive device could let some patients avoid arterial catheter placement, reducing pain and risks of ischemic and infectious complications.
How similar studies have gone: Similar non-invasive pulse-wave devices have shown mixed but sometimes promising agreement with arterial lines in surgical settings, but concordance is not uniformly established for carotid endarterectomy.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - DMU CARE
Créteil, France, France Recruiting
Study contacts
- Study coordinator: Nicolas Bertrand, MD
- Email: nicolas.bertrand@aphp.fr
- Phone: (+33) 0149835907
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.