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

Blood Pressure Clinical Trial

— NEXFIN-NRI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05283824
• Other study ID #: NEXFIN-NRI( 29BRC21.0268)
• Status: Completed
• Start date: March 19, 2022
• Est. completion date: November 8, 2022

Study information

• Verified date: July 2023
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 8, 2022
• Est. primary completion date: November 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

References & Publications (6)

Chen G, Meng L, Alexander B, Tran NP, Kain ZN, Cannesson M. Comparison of noninvasive cardiac output measurements using the Nexfin monitoring device and the esophageal Doppler. J Clin Anesth. 2012 Jun;24(4):275-83. doi: 10.1016/j.jclinane.2011.08.014. — View Citation

Hofhuizen C, Lansdorp B, van der Hoeven JG, Scheffer GJ, Lemson J. Validation of noninvasive pulse contour cardiac output using finger arterial pressure in cardiac surgery patients requiring fluid therapy. J Crit Care. 2014 Feb;29(1):161-5. doi: 10.1016/j — View Citation

Kim SH, Lilot M, Sidhu KS, Rinehart J, Yu Z, Canales C, Cannesson M. Accuracy and precision of continuous noninvasive arterial pressure monitoring compared with invasive arterial pressure: a systematic review and meta-analysis. Anesthesiology. 2014 May;12 — View Citation

Mascha EJ, Yang D, Weiss S, Sessler DI. Intraoperative Mean Arterial Pressure Variability and 30-day Mortality in Patients Having Noncardiac Surgery. Anesthesiology. 2015 Jul;123(1):79-91. doi: 10.1097/ALN.0000000000000686. — View Citation

Salmasi V, Maheshwari K, Yang D, Mascha EJ, Singh A, Sessler DI, Kurz A. Relationship between Intraoperative Hypotension, Defined by Either Reduction from Baseline or Absolute Thresholds, and Acute Kidney and Myocardial Injury after Noncardiac Surgery: A — View Citation

Scheer B, Perel A, Pfeiffer UJ. Clinical review: complications and risk factors of peripheral arterial catheters used for haemodynamic monitoring in anaesthesia and intensive care medicine. Crit Care. 2002 Jun;6(3):199-204. doi: 10.1186/cc1489. Epub 2002 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic arterial blood pressure (mmHg)	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©)	During neuroradiological procedure
Primary	Diastolic arterial blood pressure (mmHg)	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©)	During neuroradiological procedure
Primary	Mean arterial blood pressure (mmHg)	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©)	During neuroradiological procedure
Secondary	Systolic arterial blood pressure (mmHg)	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)	During neuroradiological procedure
Secondary	Diastolic arterial blood pressure (mmHg)	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)	During neuroradiological procedure
Secondary	Mean arterial blood pressure (mmHg)	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)	During neuroradiological procedure

External Links

•   Volume-Clamp Method