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

Completed

• Conditions: Blood Pressure

• Registration Number: NCT05283824
• Lead Sponsor: University Hospital, Brest

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-07
• Study First Submitted QC: 2022-03-08
• Study First Posted: 2022-03-17
• Study Start: 2022-03-19
• Primary Completion: 2022-11-08
• Study Completion: 2022-11-08
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-06
• Last Update Posted: 2023-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean arterial blood pressure (mmHg)	During neuroradiological procedure	The 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©)
Systolic arterial blood pressure (mmHg)	During neuroradiological procedure	The 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 procedure	The 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©)

Secondary Outcome Measures

Name	Time	Method
Mean arterial blood pressure (mmHg)	During neuroradiological procedure	The 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)
Systolic arterial blood pressure (mmHg)	During neuroradiological procedure	The 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 procedure	The 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)

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France