Ulnar Artery Versus Radial Artery Cannulation in Paediatric Patients: a Prospective Randomized Non-inferiority Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- overall puncture success in different arterial sites
研究概览
简要总结
Arterial cannulation is indicated in several clinical settings: high-risk surgery, respiratory failure, circulatory failure. The possible anatomical sites of cannulation are: a.radialis, a.brachialis, a. femoralis. However, the most reported complications in preschool-aged children are associated with femoral and brachial arteries. Therefore, alternative cannulation sites are being searched as ulnar artery, tibial posterior artery.
详细描述
In pediatric patients, artery cannulation may be associated with a higher risk of complications. The preferred puncture site is the radial artery or the femoral artery. However, puncture of the femoral artery in comparison with the radial artery is based on observational data as a significant risk side of post-puncture complications. The radial artery is the dominant artery of the hand, and the collateral supply (via the ulnar artery) is often unable to provide adequate peripheral perfusion. Therefore, other potential sites suitable for artery cannulation in paediatric patients are currently being investigated with the primary goal of increasing safety and reducing the risk of post-puncture complications. According to published studies, the potential alternatives are: posterior tibial artery and ulnar artery. Both arteries have comparable dimensions with radial artery and can be used for USG-guided cannulation. In this prospective randomized trial, patients with clinical indication for arterial cannulation (high-risk surgery, respiratory failure, circulatory failure) undergoing surgery under general anesthesia and pediatric patients admitted into the pediatric intensive care unit (PICU) will be randomized in form of sealed envelopes into a.radialis and a.ulnaris group as the initial site of arterial catheterization. Ultrasound (USG) measurement of both arteries will be performed before the cannulation. The catheterization success rate (number of percutaneous punctures) and overall success rate will be evaluated. The artery will be cannulated under USG control, initially in in-plane view, only in case of insufficient image, or after 2 unsuccessful attempts, the out-of-plane approach could be used. The maximum 5 percutaneous attempts and 10 minutes could be used for the initial (randomized) site of cannulation). In case of cannulation failure, the other artery could be used for cannulation. The rate of complications in 24 hours after cannulation will be evaluated. The arterial catheter will stay in place until the clinical indication remained.
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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
- Double (Participant, Outcomes Assessor)
盲法说明
randomization after general anesthesia induction, or deep sedation in PICU
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paediatric patients (1 - 6 years)
- •high risk surgery (significant blood loss or hemodynamic instability)
- •critically ill patients at PICU (respiratory failure, circulatory failure)
- •informed consent
排除标准
- •refused to participate
- •arterial catheterization not clinically relevant
结局指标
主要结局
overall puncture success in different arterial sites
时间窗: intraoperatively
defined by number of required percutaneous punctures and overall site success rate
次要结局
- Duration of catheterization(Intraoperatively)
- Interval between catheterization and catheter removal(24 hours postoperatively)
- Technique of the ultrasound-guided cannulation (in-plane/out-of-plane)(intraoperatively)
- Incidence of complications(24 hours postoperatively)
- Arteries anatomical description(intraoperatively)
研究者
Petr Štourač, MD
Clinical Professor
Brno University Hospital