Topical Nitroglycerin to Facilitate Radial Arterial Catheter Insertion in Children: a Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- change in The diameter of radial artery
研究概览
简要总结
Local nitroglycerin (NTG) was successfully used as a vasodilator to facilitate cannulation of the radial artery. NTG was used in adults by topical application as well as subcutaneous infiltration. Subcutaneous infiltration of NTG resulted in significant vasodilatation, improved palpability of the radial artery, reduced the number of punctures and the time needed for cannulation in adults. Topical NTG was reported to increase radial artery diameter in healthy volunteers without reduction in arterial blood pressure. In pediatric population, there no sufficient evidence for the effectiveness of NTG in improving radial artery cannulation. In a case report on two neonates, topical nitroderm ointment successfully reversed tissue ischemia secondary to radial artery cannulation The aim of this work is to evaluate the use of topical NTG (patch) for increasing the diameter of radial artery, improving the cannulation success, and decreasing catheter-related ischemic complications.
详细描述
A written informed consent will be obtained from patient's parents or guardians. Randomization will be obtained using computer-generated sequence. Concealment will be obtained using opaque envelopes.
On arrival to the preparing room, patients will be randomized into one of the two groups:
- NTG group or, Control group
Ultrasound examination:
The diameter of radial artery will be measured using a linear, high frequency probe (12 mHz) of Simens machine. Measurement will be obtained in the short axis plane at the point with maximal pulsation. The point will be marked to guide the post-intervention examination. The operator will be an experienced single operator blinded to the study group. Measurements will be obtained in both limbs at baseline (before application of NTG patch application,30 minutes,60minutes after NTG application After induction of anesthesia, radial artery will be punctured by 22-g catheter by an experienced anesthetist
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children aged between 2 and 5 years scheduled for cardiac surgery
排除标准
- •Systolic blood pressure less than 90 mmHg,
- •previous radial artery puncture
- •abnormal Allen's test
- •hypercoagulable states
- •coagulopathy
- •previous vascular complications
研究组 & 干预措施
NTG group
In this group, nitroglycerin patch will be applied near the radial artery pulsation covered with a gauze.
干预措施: gauze cover (Other)
NTG group
In this group, nitroglycerin patch will be applied near the radial artery pulsation covered with a gauze.
干预措施: NTG patch (Drug)
Control group
In this group, no patch as applied to the patient. However, a gauze will be applied to confirm blinding
干预措施: gauze cover (Other)
结局指标
主要结局
change in The diameter of radial artery
时间窗: 1 minutes before intervention then 30 and 60-minutes after the intervention
mm
次要结局
- palpability of radial pulse after NTG patch application(1 minutes before intervention then 30 and 60-minutes after the intervention)
- systolic blood pressure(1 minute before the intervention, every 5 minutes for 1 hour)
- postoperative ischemic complications(24 hours post intervention)
- successful first-puncture cannulation(30 minutes)
- Number of arterial punctures(30 minutes)
- successful cannulation confirmed(30 minutes)
研究者
Ahmed Hasanin
assistant professor
Cairo University