Ultrasound Guided Ulnar Versus Radial Artery Cannulation in Pediatrics Undergoing Major Non Cardiac Surgery: Double Blinded Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Rate of successful cannulation at first attempt
研究概览
简要总结
This study aims to assess the safety and efficacy of ulnar artery cannulation compared to radial artery cannulation in pediatrics undergoing major non cardiac procedures.
详细描述
The study is a double blinded randomized controlled trial that will be conducted at Abu Al Reesh Children's Hospital, Faculty of Medicine, Cairo University after approval of research and ethics committees.
Children will be recruited into the trial during pre-operative assessment. will be randomly assigned to one of two groups Recruited patients will be randomly allocated by a computer-generated sequence of codes using randomization software (https://www. randomizer.org) into one of the two groups; in a 1:1 ratio (Group R) to receive radial artery cannulation and (Group U) to receive ulnar artery cannulation using ultrasound. The randomization sequence will be concealed in sequentially numbered, sealed opaque envelopes. The sealed envelopes will be opened by an anesthesia nurse immediately before induction of anesthesia.
After induction of anesthesia, modified Allen's test will be done by the ultrasound operator as following:
An Esmarch bandage will be used to exsanguinate the selected hand for cannulation according to the operator preference for 30 seconds, then the operator will apply simultaneous pressure to the ulnar and radial arteries of the chosen limb to occlude them. The bandage will then be released. Next, the pressure over the opposed artery selected for cannulation will be released and the time (in seconds) it takes for color to return to the hand will be measured.
Allen test results will be interpreted as follows:
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- All pediatrics ASA I&II aged 1 month -10 years undergoing major non cardiac surgeries.
排除标准
- •• Patients undergoing cardiac surgeries.
- •Refusal of parents.
- •Ischemia defined as (color changes: blanching, duskiness, and or change in temperature of the extremity used for cannulation compared to the contralateral one).
- •Previous arterial cannulation within last week.
- •Patients requiring inotropic support before the start of procedures.
- •Rash or signs of infection or hematoma at the site of cannulation.
- •Patients requiring emergency procedures.
研究组 & 干预措施
(Group R)
receive radial artery cannulation using ultrasound
干预措施: ultrasound guided radial versus ulnar artery cannulation (Procedure)
(Group U)
receive ulnar artery cannulation using ultrasound
干预措施: ultrasound guided radial versus ulnar artery cannulation (Procedure)
结局指标
主要结局
Rate of successful cannulation at first attempt
时间窗: 15 minutes
(the procedure will be classified as successful when the artery is cannulated, and an arterial waveform is recorded within less than 3 attempts and or 15 minutes from the first puncture).
次要结局
- diameters of the arteries after cannulation(15 minutes from start of cannulation)
- incidence of vasospasm(15 minutes from start of cannulation)
- diameters of the arteries before cannulation(preoperative)
研究者
Khaled Abdelfattah Abdallah Sarhan
principal investigator,Lecturer of anesthesia, Cairo university
Kasr El Aini Hospital