跳至主要内容
临床试验/NCT05956028
NCT05956028已完成不适用

Efficacy of Ultrasound-guided Internal Jugular Vein Versus Supraclavicular Subclavian Vein Cannulation in Neonates and Infants Less Than 5 kg Undergoing Major Surgeries: a Prospective, Randomized Controlled Trial.

Kasr El Aini Hospital2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2023年7月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
108
试验地点
2
主要终点
The first attempt success rate.

研究概览

简要总结

The aim of this study is to compare the effectiveness and safety of ultrasound- guided IJV and supraclavicular SCV cannulation in infants weighing less than 5 kg.

详细描述

The aim of this study is to compare the effectiveness and safety of ultrasound- guided IJV and supraclavicular SCV cannulation in infants weighing less than 5 kg.

It is hypothesized that ultrasound guided supraclavicular SCV cannulation has a higher success rate compared to IJV cannulation.

Infants will be recruited into the trial during pre-operative assessment. Recruited infants will be randomly assigned to one of two groups in a 1:1 ratio; (group S) to receive ultrasound guided SCV cannulation and (group I) to receive ultrasound guided IJV cannulation. Randomization will be achieved using a computer-generated sequence. Concealment will be achieved using opaque envelopes.

All infants will be anesthetized in accordance with the local policy of pediatric anesthesia unit in Abu El-Reesh pediatric hospital-Cairo university after ethics committee approval.

After preoperative examination and upon arrival to the operating room heart rate, noninvasive blood pressure NBP and oxygen saturation SPO2 will be monitored using standard monitor (drȁger infinity vista XL) before inhalational induction of anesthesia using titration of sevoflurane in oxygen air mixture 60% (starting from 3% up to 8%) until the infant is put to sleep. After securing an intravenous line anesthesia will be completed with 1-2µg/kg of fentanyl and atracurium 0.5 mg/kg.

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
1 Day 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • • All infants weighing less than 5 kg scheduled for major elective surgeries under general anesthesia.

排除标准

  • • Parents or legally authorized personnel refusal.
  • Previous trials of central venous cannulation in the last week.
  • Emergency surgery.
  • Coagulopathy (platelets less than 20.000 and or INR more than 1.5)
  • Infection at the proposed site for cannulation.
  • Inability to visualize vein correctly by the ultrasound.
  • Neck deformity or swelling in the proposed site of cannulation.

结局指标

主要结局

The first attempt success rate.

时间窗: 1 hour

The attempt will be considered successful when smooth insertion of the guidewire into the vein.

次要结局

  • Insertion time(1 hour)
  • Number of puncture attempts.(1 hour)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Khaled Abdelfattah Abdallah Sarhan

principal investigator, Asst. professor of anesthesia, Cairo university

Kasr El Aini Hospital

研究点 (2)

Loading locations...

相似试验