跳至主要内容
临床试验/NCT04604340
NCT04604340终止不适用

Radial Versus Femoral Arterial Access for Cerebral Angiography in Adolescents: A Randomized-controlled Study

The Hospital for Sick Children2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年9月22日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
12
试验地点
2
主要终点
Procedural access-related complications

研究概览

简要总结

This study will compare radial vs femoral access for angiography in adolescents. Neuroangiography and neurointerventions are predominantly performed via femoral access, which has several limitations and complications - pain and discomfort, arterial occlusion, retroperitoneal hemorrhage, activity limitations, and increased admissions. Transradial angiography has shown promise to circumvent these problems, but this has not been studied in children, whose unique anatomical and physiological aspects require that this be evaluated rigorously.

详细描述

Specific Aims:

Angiography in interventional radiology is still most commonly performed through femoral arterial access, wherein patients are committed to invasive procedures through access at their groin, which entails anxiety, embarrassment, pain and discomfort, the inability to resume normal activities for a week, serious complications like retroperitoneal hemorrhage, and increased hospital admissions. Angiography through access at the wrist (transradial angiography) has been shown with some recent data to circumvent these complications and, in general, provide a more satisfactory and safe patient experience. Although transradial angiography has been rapidly accepted by some operators, especially in Cardiology, the absence of evidence for technical details and safety has resulted in much debate in the literature and in recent conferences. Specifically, there is no literature reported in children. The benefits of a method which would allow mobility immediately after the procedure in children are self-evident - this would potentially result in less rebleeds, require little or no sedation, allow sitting up and feeding, and allow parents to interact with their child and feel more comfortable. On the flip side, the feasibility and potential complications in children are unknown, and thus this technique cannot be integrated into clinical practice without interrogating this. This should be ideally performed in a high volume pediatric center with expertise in not only pediatric neuroangiography, but also for minimally invasive arterial access with interventional radiology, to minimize complications. Given the size consideration of arteries in children, we believe a good start point for this study would be with adolescent children.

The Investigator's objective is to provide the highest level of evidence (RCT data) for feasibility, safety and technique of transradial angiography in adolescents, by comparing it against the current gold standard, trans-femoral angiography. This will provide data for subsequent practice guidelines.

This study will be performed in a tertiary pediatric institution, with collaboration between interventional radiologists, neuroradiologists, pediatricians, neurosurgeons, technologists, statisticians, research co-ordinators and imaging physicists. A large number of clinical cases, established pipelines for clinical workflow and research collaborations and imaging laboratories with personnel and students would enable us to successfully complete this project in a timely manner.

Neuroangiography and neurointerventions are predominantly performed via femoral access, which has several limitations and complications - pain and discomfort, arterial occlusion, retroperitoneal hemorrhage, activity limitations, and increased admissions. Transradial angiography has shown promise to circumvent these problems, but this has not been studied in children, whose unique anatomical and physiological aspects require that this be evaluated rigorously.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Age 8-18 years
  • Planned cerebral or supra-aortic angiography for clinical reason
  • Positive modified Allen's test using a pulse oximeter on the index finger.
  • Radial artery axial maximal diameter of > 2.0 mm measured on a cross-sectional B-mode ultrasound of the distal radial artery, 2-3 cm proximal to the radial styloid, at the anticipated needle puncture site -

排除标准

  • Age <8 years
  • Radial artery internal maximal of diameter 2.0 mm or less (measured on cross-sectional ultrasound 2-3 cm proximal to the radial styloid at the planned puncture site) - these patients would be converted to femoral access without radial artery puncture but would be assessed in the radial artery group as part of an intention-to-treat analysis.
  • Conversion to intervention (as opposed to diagnostic cerebral angiogram) during the procedure, as this will likely require a larger (femoral) access sheath; again such patients will still be assessed as part of the intention-to-treat analysis.
  • Failed modified Allen's test with pulse oximetry

结局指标

主要结局

Procedural access-related complications

时间窗: 365 days

access-related

other Procedural complications

时间窗: 365 days

other procedural complications

Procedural complications-completion rate

时间窗: intraprocedural

study completion rate

patient/parent satisfaction score

时间窗: 3 days post-procedure

modified Likert scale-0=unsatisfied, and 5=completely satisfied

Procedural complications - long term

时间窗: 30 days

long term complications

pain score

时间窗: 3 hours post-procedure

visual analog scale VAS with 0=no pain, and 10 being worst pain

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prakash Muthusami

Neurointerventionist

The Hospital for Sick Children

研究点 (2)

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