About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
Children under 6 years of age scheduled for elective surgery under general anaesthesia at a single tertiary paediatric centre in Switzerland. Participants are recruited consecutively from the preoperative surgical list; parent/guardian consent is obtained. Setting: Department of Anaesthesiology, University Children's Hospital, Zurich, Switzerland.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Hit rate of cephalic vein within the marked and EMLA-covered area
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.
Secondary outcomes
Distance (mm)
Distance (mm) between vein center and center of marked area
Vessel diameter (mm)
Maximal vessel diameter (mm) at the marked location in transverse plane during venostasis
Vessel depth (mm)
Vessel depth (mm) from skin surface to vein center
Proximal course of the vein
Proximal course of the vein, defined as visibility and continuity of the vein over a 3 cm proximal segment (categorical: straight / curved / splitting up)
Sponsors and contacts
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Alexander Schmidt
Lead sponsor
University Children's Hospital, Zurich
Sponsor institution