Effect of Subcutaneous Nitroglycerin on the Prevention of Radial Artery Occlusion After Radial Artery Catheterization in Pediatric Patients - a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The incidence of radial arterial occlusion (RAO) (%)
研究概览
简要总结
The primary objective of the study is to evaluate the vasodilative effect of subcutaneous nitroglycerin to prevent radial arterial occlusion(RAO) after removal of the radial arterial catheter in pediatric patients. The hypothesis of this study is that subcutaneous nitroglycerin will decrease the incidence of radial arterial occlusion after radial arterial catheter removal in pediatric patients by increasing the radial artery size. This is a single-center, double-blind, randomized, placebo-controlled study comparing the effect of subcutaneous nitroglycerin and saline on radial artery cannulation and catheter removal in pediatric patients. Prior to the procedure, each patient will be randomized into either the control arm, saline, or the study arm, nitroglycerin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing General anesthesia
- •Patients in the Intensive care unit
- •Arterial cannulation for hemodynamic monitoring, or multiple blood sample
排除标准
- •Unstable vital signs, significant arrhythmia or hypotension, Shock
- •High risk of peripheral ischemia
- •Skin disease, infection, hematoma, recent cannulation at the radial artery
- •History of anaphylaxis to nitroglycerin
研究组 & 干预措施
Nitroglycerin
Nitroglycerin 5mcg/kg (in 0.5cc) is subcutaneously injected before radial artery cannulation and before removal of the radial arterial catheter.
干预措施: Nitroglycerin (Drug)
Control
Normal saline (0.5cc) is subcutaneously injected before radial artery cannulation and before removal of the radial arterial catheter.
干预措施: Normal saline (Drug)
结局指标
主要结局
The incidence of radial arterial occlusion (RAO) (%)
时间窗: After removal of the radial artery catheter (up to 24 hour)
RAO is defined as no pulse oximeter wave at the index finger during compression of the ipsilateral ulnar artery.
次要结局
- First attempt success rate (%)(During radial artery cannulation (up to 1 hour))
- Size of radial artery (mm)(Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour))
- depth of radial artery (mm)(Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour))
- flow velocity of the radial artery (cm/s)(Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour))
- Perfusion index(Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour))
- Overall attempt (number)(During radial artery cannulation (up to 1 hour))
- Overall Procedure time (seconds)(During radial artery cannulation (up to 1 hour))
- Overall success rate (%)(During radial artery cannulation (up to 1 hour))
- Incidence of posterior wall puncture (%)(During radial artery cannulation (up to 1 hour))
- Number of arteries cannulated(During radial artery cannulation (up to 1 hour))
- Malfunction of radial artery catheter(After radial artery cannulation assessed during anesthesia (per 24hour, up to 480 hour))
- Complication rate(After radial artery cannulation assessed up to PACU, PICU stay (per 24hour, up to 480 hour))
- Duration of radial arterial catherization(After radial artery cannulation assessed during anesthesia (up to 480 hour))
研究者
Young-Eun Jang
Clinical assistant professor
Seoul National University Hospital