Development of a Landmark-formula for Distal Cephalic Vein Localization and Validation Study of Accuracy in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Hit rate of cephalic vein within the marked and EMLA-covered area
研究概览
简要总结
In children undergoing surgery, a venous access line almost always has to be placed. Through this line, medications and fluids can be administered during anesthesia or later during the hospital stay. In young children, it is often difficult to find a suitable vein. This can lead to multiple puncture attempts and may be a traumatic experience for both children and their parents. With ultrasound, however, in such difficult cases a specific vein on the forearm (the "cephalic vein") can usually be visualized and cannulated. Mostly, this vein is not visible to the naked eye.
In our research project, we aim to determine whether it is possible to identify a simple and reliable anatomical orientation aid ("landmark") on the forearm that enables parents to place a topical anesthetic EMLA patch precisely at the correct location where the vein can subsequently be found using ultrasound. In this way, we want to assess whether this method simplifies the preparation for venipuncture and thereby increases the success rate. The examination is carried out during the routine preparation for anesthesia.
In a first step, the course of the vein is identified by ultrasound, marked on the skin in a controlled manner, and photographic documentation of the forearm region is created. From this, a visual orientation guide describing the landmark is developed. In a second step, parents and staff of the anesthesia department mark the defined landmark using this visual orientation guide. Ultrasound is then used again to verify whether the vein is located at the marked site. No additional needle puncture is performed and no additional blood sample is taken.
详细描述
This study is a prospective, single-center, observational validation study designed to develop and evaluate a reproducible external anatomical landmark for localization of the distal cephalic vein at the forearm in pediatric patients. The study aims to support accurate preprocedural placement of topical local anesthetic (EMLA) and to facilitate subsequent peripheral venous access in children by using ultrasound as the reference standard.
Background and Rationale
Peripheral venous access in young children is frequently challenging due to limited visibility and palpability of superficial veins. The cephalic vein at the distal forearm is a commonly used site for ultrasound-guided cannulation; however, standardized external anatomical landmarks for preprocedural localization of this vein are lacking, particularly in pediatric patients. As a result, opportunities for timely application of topical anesthetics are often missed, especially in ambulatory and day-surgery settings where parents are required to apply EMLA patches at home prior to hospital admission.
Ultrasound provides accurate visualization of superficial venous anatomy and allows objective validation of surface landmark accuracy. This study seeks to define a practical, reproducible landmark for the distal cephalic vein and to assess whether this landmark can be applied reliably by anesthesia professionals as well as by parents or caregivers using a standardized visual instruction guide.
Study Design and Setting
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 5 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children under the age of 6 years
- •Scheduled elective procedure under general anesthesia
- •Admission via the surgical day clinic
- •Written informed consent by the parents (and by the child if capable of judgment)
排除标准
- •pre-existing intravenous access at the investigation site
- •Skin conditions or infections at the forearm site
- •Known allergy to EMLA or any of its components
结局指标
主要结局
Hit rate of cephalic vein within the marked and EMLA-covered area
时间窗: Baseline (one ultrasound-examination after induction of anesthesia for planned surgery)
Proportion of cases where the cephalic vein is found within the user-marked area (staff or parent) and covered by the EMLA patch. (binary: yes/no). All outcome measures are assessed by ultrasound under general anesthesia.
次要结局
- Distance (mm)(Baseline (one ultrasound-examination after induction of anesthesia for planned surgery))
- Vessel diameter (mm)(Baseline (one ultrasound-examination after induction of anesthesia for planned surgery))
- Vessel depth (mm)(Baseline (one ultrasound-examination after induction of anesthesia for planned surgery))
- Proximal course of the vein(Baseline (one ultrasound-examination after induction of anesthesia for planned surgery))
- Correlation of venous anatomy and patient characteristics(Baseline (one ultrasound-examination after induction of anesthesia for planned surgery))
- Feasibility comparison(Baseline (one ultrasound-examination after induction of anesthesia for planned surgery))
研究者
Alexander Schmidt
Vice Chief Department of Pediatric Anesthesia & Program Director for Research and Education, University Children's Hospital Zurich
University Children's Hospital, Zurich
