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Comparison of 3 Techniques for Blood Pressure Measurements During Interventional Neuroradiology Procedures

Comparison of 3 Techniques for Blood Pressure Measurements During Interventional Neuroradiology Procedures

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05283824
Acronym
NEXFIN-NRI
Enrollment
50
Registered
2022-03-17
Start date
2022-03-19
Completion date
2022-11-08
Last updated
2023-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

Brief summary

Some observational studies demonstrated that hypotension was associated with post-operative morbidity. During neuroradiological procedures, cerebral perfusion pressure should be cautiously maintained and hypertension should also be avoided. So, a precise arterial pressure measurement is needed during this procedures. A continuous monitoring of arterial pressure needed the placement of an arterial catheter in radial artery. The placement of this catheter might be long, difficult and incompatible with emergency neuroradiological procedure (such as thrombectomy). Then, this invasive technique is associated with several minor and major side effects such as: pain, infection, thrombosis, hematoma. The Clearsight®, commercialized by Edwards Life Science Company®, is a non invasive device which mesure continuously arterial pressure with Volume-Clamp method. In operating room, some studies found a good accuracy between Clearsight® and other invasive monitoring system. There is no description of the use of Clearsight® during neuroradiological procedures. The investigators hypothesized that Clearsight® measurement of arterial pressure are concordant with arterial pressure measure with the placement of an arterial catheter. The investigators also plan to evaluate accuracy of intermittent non invasive pressure measurement with traditional cuff.

Interventions

None listed

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients (Age \> 18 years old) * Elective or emergent neuroradiological procedure under general or local anesthesia for : Endovascular treatment of cerebral aneurysms / arteriovenous malformation, Thrombectomy, Arteriography, transluminal balloon angioplasty for vasospasm * Placement of arterial catheter for the measurement of continuous arterial pressure

Exclusion criteria

* Contraindication of placement of arterial catheter or digital cuff (Clearsight) such as: Reynaud syndrome, Buerger syndrome * Pregnant women * Refusal

Design outcomes

Primary

MeasureTime frameDescription
Systolic arterial blood pressure (mmHg)During neuroradiological procedureThe main objective of this study is to evaluate concordance of systolic arterial pressure pressure (in mmHg) measurement between invasive (arterial catheter) and non invasive technique (Clearsight©)
Diastolic arterial blood pressure (mmHg)During neuroradiological procedureThe main objective of this study is to evaluate concordance of diastolic arterial pressure pressure (in mmHg) measurement between invasive (arterial catheter) and non invasive technique (Clearsight©)
Mean arterial blood pressure (mmHg)During neuroradiological procedureThe main objective of this study is to evaluate concordance of mean arterial pressure pressure (in mmHg) measurement between invasive (arterial catheter) and non invasive technique (Clearsight©)

Secondary

MeasureTime frameDescription
Systolic arterial blood pressure (mmHg)During neuroradiological procedureThe main objective of this study is to evaluate concordance of systolic arterial pressure pressure (in mmHg) measurement between invasive (arterial catheter) and non invasive technique (classical harm cuff)
Diastolic arterial blood pressure (mmHg)During neuroradiological procedureThe main objective of this study is to evaluate concordance of diastolic arterial pressure pressure (in mmHg) measurement between invasive (arterial catheter) and non invasive technique (classical harm cuff)
Mean arterial blood pressure (mmHg)During neuroradiological procedureThe main objective of this study is to evaluate concordance of mean arterial pressure pressure (in mmHg) measurement between invasive (arterial catheter) and non invasive technique (classical harm cuff)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026