Efficacy of an Infrared Visualization Technique for the Identification of the Peripheral Venous Access Site in Patients With Cystic Fibrosis Aged 12 Years and Older
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 271
- 试验地点
- 6
- 主要终点
- Proportion of patients for whom peripheral venous access was performed from the first attempt.
研究概览
简要总结
Cystic fibrosis is a rare chronic genetic disease that mainly affects the respiratory tract and the digestive system. Their management includes multi-year intravenous antibiotic treatments and repeated venous sampling. The venous access is a source of difficulties that nurses who take care of these patients face on a daily basis. In addition, multiple attempts at punctures can induce anxiety and pain in patients. It is therefore important to limit failures.
Vein visualization technologies exist: guidance echo, portable trans lumination or infrared visualization can guide venipuncture and limit failures.
Compared with the guided echo or the portable trans lumination, the infrared visualization is easy to use and does not pose a risk for the patient. Nevertheless, studies evaluating this technique are few in chronic diseases and mainly conducted in young children.
This study aims to show that the use of a vein illumination system (VIS) should improve the peripheral venous access at the first attempt (thus limiting venous lesions) in adolescent and adult patients with cystic fibrosis, and improve comfort of the patient (pain, apprehension of the gesture).
详细描述
Background :
Cystic fibrosis is a rare chronic genetic disease that mainly affects the respiratory tract and the digestive system. Their management includes multi-year intravenous antibiotic treatments and repeated venous sampling. The venous access is a source of difficulties that nurses who take care of these patients face on a daily basis. In addition, multiple attempts at punctures can induce anxiety and pain in patients. It is therefore important to limit failures.
Vein visualization technologies exist: guidance echo, portable trans lumination or infrared visualization can guide venipuncture and limit failures.
Compared with the guided echo or the portable trans lumination, the infrared visualization is easy to use and does not pose a risk for the patient. Nevertheless, studies evaluating this technique are few in chronic diseases and mainly conducted in young children.
This study aims to show that the use of a vein illumination system (VIS) should improve the peripheral venous access at the first attempt (thus limiting venous lesions) in adolescent and adult patients with cystic fibrosis, and improve comfort of the patient (pain, apprehension of the gesture).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cystic fibrosis aged 12 years and over
- •Cystic Fibrosis diagnosis has been confirmed by a positive sweat test and/or 1 to 2 genetic mutations
- •Patients requiring peripheral venous access (hand, forearm, or more of the elbow) for intravenous infusion with epicranial or short catheter, or for a blood sample
- •Patients who have a score of 4 or higher on the A-DIVA scale (self-administered questionnaire completed by the IDE assessing the difficulty of peripheral venous access on a Likert scale from 0 to 8)
- •Patients informed in writing of the terms of the study and provided written informed consent to participate (consent of the person in charge of parental authority if the patient is a minor).
- •Patients affiliated to a social security system
排除标准
- •Patient who has already participated in the study
- •Patients who have a central venous approach
- •Patients who have a venous approach of the midline type
- •Patients taken care of for vital emergency
- •Patient deprived of liberty or placed under tutorship or curatorship
研究组 & 干预措施
Control Group
Patients who have a peripheral venous access by a classic procedure, without using a Vein Illumination System.
Experimental Group
Patients who have a peripheral venous access by a procedure using a Vein Illumination System.
干预措施: Vein Illumintion System device (Device)
结局指标
主要结局
Proportion of patients for whom peripheral venous access was performed from the first attempt.
时间窗: at time of peripheral venous access
次要结局
- Average pain score on Visual Analogue Scale (VAS) after successful peripheral venous access act.(at most 10 min after the venous act)
- Number of attempts to place a peripheral venous line or perform peripheral venous(at time of peripheral venous access)
- Average anxiety score on State-Trait Anxiety Inventory (STAI-Y)(at most 10 min before the venous act)
- Proportion of nurses and nursing student satisfied by the use of a vein illumination system(at the end of the study ( at 14 months))