Efficacy of AccuVein V400 to Facilitate Peripheral Intravenous Placement in Sickle Cell Disease Adults With Vaso-occlusive Crisis : a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 3
- 主要终点
- Number of venipunctures
研究概览
简要总结
The primary goal of this randomized, controlled, open-label study is to determine the efficacy of AccuveinV400 (a transillumination veins device) to facilitate peripheral intravenous (IVP) catheter placement during a vaso-oclusive crisis. The investigators hypothesized that the number of attempts to a successful placement of a peripheral IV, our primary outcome, would be shorter with the assistance of the Accuvein V400. It is also expected that AccuveinV400 will reduce the time of the procedure, the rate of failure, the technique-related pain.
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
- 否
入选标准
- •Sickle cell patients (all genotypes)
- •Patients hospitalized for uncomplicated vaso-occlusive crisis (CVO) in Internal/general Medicine department
- •Patients requiring the placement or replacement of a peripheral intra-venous catheter in the Department of Internal/general Medicine
- •Patients arrived in the internal/general medicine department of the hospital between 9h and 18h and except weekends
- •Signed informed consent.
- •Affiliated to the French health care insurance.
排除标准
- •Signs of shock
- •Acute chest Syndrome
- •Central venous catheter already present
- •Indication to have a central venous catheter from the ourset
- •Patient who has already participated to the PERFID study during the current hospitalization
- •Refusal of the patient's participation
- •Pregnant or lactating woman
- •Patient under guardianship or curatorship
结局指标
主要结局
Number of venipunctures
时间窗: Time of the infusion procedure
Number of venipunctures until the peripheral IV placement (with a retrograde blood sample) or before failure (discontinuation after at least 3 attempts by 2 nurses and a maximum of 9 attempts in total).
次要结局
- The need of a central venous catheter(Time of the infusion procedure)
- Anxiety before and after the procedure(Just before and within 1 hour after a successful peripheral IV placement)
- Patient satisfaction (pain)(Within 1 hour after a successful peripheral IV placement)
- Qualitative interview of the Accuvein use(An average of one week after the procedure)
- Patient bone pain before and after the procedure(Before and within 1 hour after a successful peripheral IV placement)
- Nurse satisfaction (procedure)(Within 1 hour after a successful peripheral IV placement)
- Nurse satisfaction (quality of placement)(Within 1 hour after a successful peripheral IV placement)
- Side effects of the procedure(Time of the infusion procedure)
- Time of the procedure(Time of the infusion procedure)
- Patient satisfaction (procedure)(Within 1 hour after a successful peripheral IV placement)
- Procedure failure(Time of the infusion procedure)