The Effect of Peripheral Intravenous Catheter Bundle on Catheter Insertion Success, Complication Development, and Procedure-Related Pain in Patients Presenting to the Pediatric Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- PIVC insertion related pain score
研究概览
简要总结
The study was designed to investigate the effects of a PIVC Bundle, which includes a vein visualization device and a vial (BD Neoflon™ Pro catheter), on catheter placement success, complications, procedure-related pain, and catheter length of stay in children aged 1-6 years who are scheduled for peripheral intravenous catheter (PIVC) insertion.
详细描述
The study sample included four groups: (1) vein visualization device (VGC) and Vialon Catheter Group, (2) VGC and Standard/Teflon Catheter Group, (3) Vialon Catheter Group, (4) Standard/Teflon Catheter Group/Control Group. Data were collected using the Socio-Demographic Data Collection Form, the Forced Intravenous Intervention Score, the PIVC Site Follow-up Form, the Infiltration Scale, the Extravasation Scale, the Phlebitis Scale, and the FLACC Pain Diagnosis Scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •must be between 1 and 6 years old.
- •must be inserted PIC
排除标准
- •must be shock or severe dehydration, unconsciousness.
- •had a central catheter.
- •must be inserted at the lower extremities.
研究组 & 干预措施
Vein Imaging Device and Vialon Catheter Group
Using a PIVC bundle,Vein Imaging Device, and Vialon catheters
干预措施: Vein Imaging Device (Device)
Vein Imaging Device and Vialon Catheter Group
Using a PIVC bundle,Vein Imaging Device, and Vialon catheters
干预措施: Vialon catheters (Device)
Vein Imaging Device and Standard/Teflon Catheter Group
Using a PIVC bundle,Vein Imaging Device, and Teflon catheters
干预措施: Vein Imaging Device (Device)
Vialon Catheter Group
Using a PIVC bundle and Vialon catheters
干预措施: Vialon catheters (Device)
Standard/Teflon Catheter Group
Using a PIVC bundle and Teflon catheters
结局指标
主要结局
PIVC insertion related pain score
时间窗: FLACC score evaluated 3 minutes after the PIVC insertion
The FLACC (Face, Legs, Activity, Cry, Consolability) score related to the PIVC insertion. The scale is scored in a range of 0-10, with 0 representing no pain. Assessment of score: 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
PIVC indwelling time
时间窗: immediately after the PIC intervention
PIVC stay time
次要结局
未报告次要终点
研究者
Gülçin Özalp Gerçeker
Prof.
Dokuz Eylul University