Comparison of Arterial Cannulation by Direct Waveform Assistance (DiWA) Against Ultrasound Guided Arterial Cannulation: A Randomized Non-Inferiority Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Evaluate if DiWA is non-inferior to ultrasound-guided arterial cannulation in terms of first-attempt success rate.
研究概览
简要总结
Arterial cannulation is a common procedure done in operating theatres and intensive care units for continuous blood pressure recording as well as frequent blood sampling. It is usually done by palpatory methods as well as ultrasound-guided. Ultrasound has various advantages as compared to palpatory methods such as real-time guidance, fewer chances of failure or formation of hepatoma/ vasospasm. The disadvantage of ultrasound is its cost and availability. To overcome this disadvantage, a new technique using Direct waveform assistance is being proposed in which an arterial cannula is attached to a pressure transducer through a pressure monitoring line and the pressure waveform appears on the monitor once the cannula is inside the artery. This technique will be used for the first time in this study. It has given promising results in a few pilot cases. Hence, this is planned to compare arterial cannulation guided by direct waveform assistance (DiWA) with ultrasound in patients requiring arterial cannulation under general anaesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients aged 18 to 65 years, either gender, American Society of Anaesthesiologists (ASA) physical status 1-3 requiring arterial cannulation under general anaesthesia for elective or emergency surgeries will be included in the study.
排除标准
- •Refusal to participate, surgery under regional anaesthesia, negative modified Allen’s test for collaterals, patients with a diagnosis of peripheral vascular disease, surgery at the radial artery site, coagulation disorders, hemodynamically unstable patients, obese patients BMI more than 35, burns at arterial puncture site, local site infection.
结局指标
主要结局
Evaluate if DiWA is non-inferior to ultrasound-guided arterial cannulation in terms of first-attempt success rate.
时间窗: baseline and at 24hours
次要结局
- Time to be required for successful cannulation(in seconds/ minutes)
- Number of redirections needed for arterial cannulation.(1-3)
- Number of attempts for successful cannulation(1-3)
- Overall success or failure rates(Successful/ failure)
- Rate of complications at arterial puncture site such as hematoma formation, vasospasm following arterial cannulation.(between 0 to 100%)
研究者
Dr Lekha B Kallappagoudra
Post Graduate Institute of Medical education and Research