Evaluation of the Efficacy of Transillumination on Peripheral Venous Line Placement in Patients With a Difficult Vascular Approach Who Are Managed in the Emergency Department.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 主要终点
- Percentage of patients for whom peripheral venous vein placement was successful on the first attempt
研究概览
简要总结
When taking care of an emergency patient (Emergency Reception Service: UAS and Urgent Medical Assistance Service: SAMU), the installation of a peripheral venous route (VVP) is an important step. The benchmark method is the most widely used technique. This vascular access will allow the necessary therapy to be delivered quickly and efficiently. This can be difficult and sometimes doomed to failure for reasons related both to the patient (venous capital not very visible / felt or limited due to the profile of the patient), or sometimes also for reasons related to the patient. environment (limited lighting, difficult patient access). The only current alternatives lie in the use of a device such as the Intra-Bone Device (IID) or the installation of a central venous line. On the other hand, these alternatives are particularly invasive and / or very algogenic.
There are other techniques, which are more affordable and "transportable" outside the hospital. Indeed, trans-illumination with a very short training seems to be a particularly interesting alternative. It allows, thanks to LEDs in contact with the skin, to backlight the superficial veins.
It is proposed through this project to evaluate this tool for a category of patients considered "difficult" to infuse, both within hospital and outside hospital.
The main objective of the study is to assess the effectiveness of the transillumination device, compared to the absence of such a device, on the placement of a peripheral venous line (PVP) in patients with a difficult vascular approach and managed in the emergency room and whose clinical condition does not require the installation of an intraosseous device.
This is a multicenter, prospective, controlled, randomized and open clinical study, according to a cross-over design. The intervention evaluated is the placement of a PVR using the trans-illumination device. The control intervention is the placement of a PVR without this device, according to the reference method, which is the benchmark method.
400 patients presenting to the emergency room will be included in the centers of Nancy, Toul and Pont-à-Mousson.
Depending on their randomization group, nurses will perform peripheral venous insertion by the transillumination method or by the control method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •>= 18 years old
- •extrem body mass index
- •hypotension
- •toxicomania
- •limited ponction site
- •hypotherm patient
- •dehydrated patient
- •generalized edema
- •non-supportive environment
排除标准
- •parturient / pregnant female / breastfeeding mother
- •unemancipated minor
- •adults under legal protection
- •person under judicial protection, guardianship or curatorship
结局指标
主要结局
Percentage of patients for whom peripheral venous vein placement was successful on the first attempt
时间窗: immediately after procedure
次要结局
- number of attempts before successful venous line placement(during the procedure)
- The caliber of the peripheral venous route(during the procedure)
- nurse stress(during the procedure)
- patient pain(during the procedure)
