Non-invasive continuous blood pressure monitoring during carotid endarterectomy
Continuous Non-invasive Blood Pressure Monitoring During Carotid Endarterectomy Surgery
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 |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Créteil, France) |
| Trial ID | NCT06965257 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Créteil, France
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.