Infrared Illumination for Difficult Peripheral Venous Catheterization in Adult Critically-ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- Percentage of primary success of peripheral venous catheterization in the upper limbs.
研究概览
简要总结
Peripheral venous catheterization is a fundamental part of the management of critically-ill patients, especially for administration of intravenous emergency treatments. In general, it is preferred to central catheterization whenever possible, since it is less invasive, achievable immediately by the nurse, and responsible for fewer complications.
Venous access difficulties are frequent in critically-ill patients. Among tools proposed to improve the practice of peripheral catheterization, ultrasound and infrared illumination are the most studied, the latter being simpler. Infrared illumination has never been evaluated in intensive care. However, the delay or failure of peripheral catheterization is highly detrimental in the context of resuscitation as it may delay or impede appropriate management of vital emergencies. Our study will focus on the peripheral venous catheterization of the upper limbs, as these are the reference site for this technique The objective is to evaluate the interest of infrared illumination (AccuVein AV500®) for the primary success (first puncture) of peripheral venous catheterization of the upper limbs in patients with resuscitation at risk of catheterization venous difficult.
It is a comparative, superiority, prospective, multicenter, randomized, controlled, open-label, phase III trial. Subjects will be divided into two groups with a 1: 1 ratio. Nurses at participating centers will be trained for the use of the device prior to the start of the study; the use of the device is singularly easy and intuitive.
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
- •Age ≥ 18 years; Hospitalization in intensive care;
- •Need for a peripheral venous catheter;
- •Risk of difficult peripheral venous catheterization. In practice, this risk will be considered present if it is impossible to palpate and / or visualize the upper end of the target vein and / or if the estimated vein diameter is smaller than 2mm. This definition is derived from the A-DIVA score (Loon FAJ van et al3).
- •Affiliation to the social security
排除标准
- •Patient who has already been enrolled in the ICARE study during the current hospitalization;
- •Refusal of patient's participation
研究组 & 干预措施
Infrared illumination group
The nurse uses the Accuvein® device to identify the veins before puncture.
干预措施: ACCUVEIN (Device)
Control group
The nurse proceeds as usual (visual identification in the light of the room and palpation)
结局指标
主要结局
Percentage of primary success of peripheral venous catheterization in the upper limbs.
时间窗: Day 1
success defined as the need of a single puncture for the effective catheterization. The effective catheterization is confirmed by obtaining venous reflux by declivity of the infusion bag.
次要结局
- Number of punctures required for peripheral venous catheterization.(Day 1)
- Rate of failure of the procedure, defined by the absence of placement of a peripheral venous catheter before the end of the procedure(Day 1)