Ultrasound Guided Central Venous Vascular Access - Novel Needle Navigation Technology Compared With Conventional Method: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- The procedure efficacy justified by successful cannulation.
研究概览
简要总结
Background: Central venous catheter (CVC) insertion is a very common procedure in the intensive care setting. A recent international guidelines advocated the use of ultrasound for routine internal jugular CVC insertion. The needle navigation technology is a new innovation, also known as guided positioning system (GPS) which allows clinician to visualize the needle position and trajectory in real time as it approaches the target. We hypothesised that the use of GPS would increase success rate and decrease performance time in vascular access procedures.
Objectives: To compare the success, efficacy and safety of the procedure using the ultrasound guidance (UG) with conventional versus GPS method.
Methods: This was a prospective randomized controlled study in a single centre - intensive care unit. 100 patients were randomized into two groups (50 each each). Subjects would receive CVC insertion via internal jugular vein using ultrasound guidance out of plane approach by conventional versus GPS method. Outcomes measured were the procedure efficacy, safety, level of operators' experience and their satisfaction.
详细描述
Introduction Central venous catheter (CVC) insertion is a very common procedure in the intensive care setting. A recent international guideline advocates the use of ultrasound for routine internal jugular central venous catheter insertion1. The needle navigation technology is a new innovation, also known as guided positioning system (GPS) which allows clinician to visualize the needle position and trajectory in real time as it approaches the target. We hypothesised that the use of GPS would increase success rate and decrease performance time in vascular access procedures. The objectives of this study are to compare the success, efficacy and safety of central venous catheter insertion via internal jugular vein using the ultrasound guidance with conventional method versus needle navigation technology.
Methods:
This was a prospective randomized controlled study. It was conducted in a single centre - intensive care unit (ICU), University of Malaya Medical Centre, Kuala Lumpur, Malaysia from February 2016 to October 2016. The ethic committee approval was obtained from the Malaysian medical research and ethics committee, MREC at the www.nih.gov.my (NMRR-16-334-29476).
The inclusion criterion was patients in the ICU who required central venous vascular access. The exclusion criteria were refusal to participate in this study by patient or their legal representative and patient with known history of difficult central venous access at internal jugular vein (IJV). The procedure operators were doctors in anaesthesia residency program with various level of experiences classified into 3 groups: 1 to < 2 years, 2 to < 3years, 3 years and above. Simply speaking all the operators have had previous training in ultrasound guided vascular access procedure. This would ensure that patient's safety is not compromised.
Study would be proceeded after obtaining consent from patient or the next of kin. The emergency verbal consent would be taken if the next of kin was not immediately available with subsequent written consent to follow. The available operator would perform CVC insertion via IJV using ultrasound guidance out of plane approach either with conventional method or needle guidance technology.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in the ICU who required central venous vascular access.
排除标准
- •Refusal to participate in this study by patient or their legal representative and patient with known history of difficult central venous access at internal jugular vein (IJV).
结局指标
主要结局
The procedure efficacy justified by successful cannulation.
时间窗: 0-120 seconds
The procedure efficacy justified by successful cannulation based on the performance time and number of attempts,
次要结局
- Safety of procedure and complications.(During and within 24 hours after procedure.)
- Operators' satisfaction.(within 1 week)
研究者
Dr Mohd Shahnaz, MBBS, M Anes
Assoc. Prof.
University of Malaya
