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临床试验/NCT05283824
NCT05283824已完成不适用

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

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年3月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Mean arterial blood pressure (mmHg)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Mean arterial blood pressure (mmHg)

时间窗: 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)

时间窗: 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)

时间窗: 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©)

次要结局

  • Mean arterial blood pressure (mmHg)(During neuroradiological procedure)
  • Systolic arterial blood pressure (mmHg)(During neuroradiological procedure)
  • Diastolic arterial blood pressure (mmHg)(During neuroradiological procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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