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临床试验/NCT03217019
NCT03217019已完成不适用

Comparison of Radial Artery Cannulation Technique in Pediatric Patients: Direct Versus Guidewire-assisted

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年8月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
success rate at 1st attempt (%)

研究概览

简要总结

In neonate and infant, radial artery cannulation may be challenging and multiple attempts are required because of the small diameter.

The invastigators will compare the success rates of radial arterial cannulation with a guidewire-assisted technique and the direct technique in pediatric patient(<1yr).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
— 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients undergoing general anesthesia with arterial cannulation (for hemodynamic monitoring or blood sampling)

排除标准

  • Skin lesion, infection, hematoma, recent cannulation at cannulation site
  • Unstable radial pulse (d/t unstable vital sign, or arrhythmias)

研究组 & 干预措施

Guidewire

Experimental
  1. Radial artery puncture with direct radial pulse palpation.
  2. 24G angiocatheter insertion with guidewire-assist. (Catheter over guidewire)

干预措施: Guidewire-assist (Procedure)

Direct

Active Comparator
  1. Radial artery puncture with direct radial pulse palpation.
  2. 24G angiocatheter insertion without guidewire-assist. (Catheter over needle)

干预措施: Direct (Procedure)

结局指标

主要结局

success rate at 1st attempt (%)

时间窗: from arterial cannulation to successful invasive BP monitoring (up to 1 hour)

successful catheter insertion after obtaining 1st blood flush in angiocatheter.

次要结局

  • total elapsed time (seconds)(from arterial cannulation to successful invasive BP monitoring (up to 1 hour))
  • number of total catheter used (number)(from arterial cannulation to successful invasive BP monitoring (up to 1 hour))
  • number of total cannulation attempts (number)(from arterial cannulation to successful invasive BP monitoring (up to 1 hour))
  • malfunction of arterial line(from the start of invasive BP monitoring until the end of anesthesia (up to 1 day))
  • complications(from the arterial cannulation until the end of anesthesia (up to 1 day))

研究者

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

Jin-Tae Kim

Professor

Seoul National University Hospital

研究点 (1)

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