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

NCT ID: NCT05283824

Last Updated: 2023-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-19

Study Completion Date

2022-11-08

Brief Summary

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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

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Conditions

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Blood Pressure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xavier CHAPALAIN, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Surgical ICU, Brest University Hospital

Locations

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CHRU de Brest

Brest, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 24637618 (View on PubMed)

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.

Reference Type RESULT
PMID: 25929547 (View on PubMed)

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.

Reference Type RESULT
PMID: 27792044 (View on PubMed)

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.

Reference Type RESULT
PMID: 12133178 (View on PubMed)

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.

Reference Type RESULT
PMID: 24475498 (View on PubMed)

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.

Reference Type RESULT
PMID: 22608581 (View on PubMed)

Chapalain X, Morvan T, Gentric JC, Subileau A, Jacob C, Cadic A, Caillard A, Huet O. Continuous non-invasive vs. invasive arterial blood pressure monitoring during neuroradiological procedure: a comparative, prospective, monocentric, observational study. Perioper Med (Lond). 2024 Jul 22;13(1):77. doi: 10.1186/s13741-024-00442-3.

Reference Type DERIVED
PMID: 39034414 (View on PubMed)

Related Links

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Other Identifiers

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NEXFIN-NRI( 29BRC21.0268)

Identifier Type: -

Identifier Source: org_study_id

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