Interest of the Ultrasound Guidance for the Laying of Femoral Arterial and Venous Catheters in Intensive Care Unit: A Controlled, Randomized Trial: The ECHOGUIDE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Proportion of complications 1 week after catheter set-up.
研究概览
简要总结
The femoral approach is the preferred vascular access for the set-up of emergency catheters in severely traumatized patient. This location combines simplicity and speed of installation, it allows the simultaneous set-up of arterial and venous catheters, and is a provider of few complications and failures.
The ultrasound guidance has greatly reduced installation times, failures and complications related to the set-up of central venous catheter. This was amply demonstrated in the internal jugular and subclavian site outside of extreme emergency situations (Fragou M et al 2011, Farrell J et al 1997, Karakistos et al 2006). The benefit of ultrasound guidance for the set-up of arterial and venous catheters in the femoral emergency has not been evaluated in terms of reduction in complications.
Then the main objective of this study is to demonstrate that the ultrasound guidance reduces early complications related to the set-up of arterial and venous catheters in the femoral emergency, among severely traumatized patient compared to the reference anatomical technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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
- •Included in intensive care unit for severe trauma
- •Need for implementation of femoral arterial and venous catheters in accordance with the practices of the service.
- •Agreed to participate
- •Affiliation to national security
排除标准
- •Contraindication to the set-up of vascular access in femoral position (femoral Scarpa wound, aortic dissection)
- •Local infection
- •Hypothermia <32°C
- •Need for implementation of arterial catheter only
- •Need for implementation of venous catheter only
研究组 & 干预措施
Ultrasound guidance
46 patients in the experimental ultrasound group
干预措施: venous and arterial catheter set-up using ultrasound guidance (Procedure)
Anatomical guidance
46 patients in the anatomical group
干预措施: Anatomical guidance. (Procedure)
结局指标
主要结局
Proportion of complications 1 week after catheter set-up.
时间窗: 1 week.
The primary end point is the proportion of patients with a complication one week after arterial and venous catheter set-up. Complications will be defined as follows: * mechanical immediate complications (hematoma, bleeding, dysfunction or non-function of the catheter, or aberrant course subcutaneous catheter) * Mechanical complications remote installation catheters (arteriovenous fistula, pseudoaneurysm), thrombotic complications. Vascular assessment will be conducted by an angiologist, using doppler ultrasound of the femoral vessels. Assessment will be made blind from the use of ultrasound guidance during installation.
次要结局
- Cannulation time between the 2 groups(the day of surgery (Day 1))
- Success of cannulation(the day of intervention (Day 1))
- Number of cannulation attempt(the day of intervention (Day 1))
- Number of puncture attempt(day of intervention (Day 1))
- total catheter set-up time between the 2 groups(the day of intervention (Day 1))