A New Landmark-formula for Cephalic Vein in Children

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 5
SponsorAlexander Schmidt

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (one ultrasound-examination after induction of anesthesia for planned surgery)

Secondary outcomes

1

Distance (mm)

Distance (mm) between vein center and center of marked area

Time frame
Baseline (one ultrasound-examination after induction of anesthesia for planned surgery)
2

Vessel diameter (mm)

Maximal vessel diameter (mm) at the marked location in transverse plane during venostasis

Time frame
Baseline (one ultrasound-examination after induction of anesthesia for planned surgery)
3

Vessel depth (mm)

Vessel depth (mm) from skin surface to vein center

Time frame
Baseline (one ultrasound-examination after induction of anesthesia for planned surgery)
4

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)

Time frame
Baseline (one ultrasound-examination after induction of anesthesia for planned surgery)

Other outcomes

Sponsors and contacts

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Alexander Schmidt

Lead sponsor

University Children's Hospital, Zurich

Sponsor institution