Clinical trial NCT05283824: Comparison of 3 Techniques for Blood Pressure Measurements During Interventional Neuroradiology Procedures
Official title: Comparison of 3 Techniques for Blood Pressure Measurements During Interventional Neuroradiology Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients, admitted in operating room elective or emergent neuroradiological procedure

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.


Eligibility criteria: 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

Primary outcomes:
measure: Systolic arterial blood pressure (mmHg)
timeFrame: During neuroradiological procedure
measure: Diastolic arterial blood pressure (mmHg)
timeFrame: During neuroradiological procedure
measure: Mean arterial blood pressure (mmHg)
timeFrame: During neuroradiological procedure
Secondary outcomes:
measure: Systolic arterial blood pressure (mmHg)
timeFrame: During neuroradiological procedure
measure: Diastolic arterial blood pressure (mmHg)
timeFrame: During neuroradiological procedure
measure: Mean arterial blood pressure (mmHg)
timeFrame: During neuroradiological procedure
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: Department of Anesthesiology and Surgical ICU, Brest University Hospital
name: Xavier CHAPALAIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
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;120(5):1080-97. doi: 10.1097/ALN.0000000000000226.
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.
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 Retrospective Cohort Analysis. Anesthesiology. 2017 Jan;126(1):47-65. doi: 10.1097/ALN.0000000000001432.
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 Apr 18.
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.jcrc.2013.09.005.
citation: 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.