A New Landmark-formula for Cephalic Vein in Children

NCT07333846 | Recruiting

• 1 other identifier: KEK-ZH-Nr.: 2025-01 980
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Venipuncture; Ultrasound; Difficult Intravenous Access in Pediatrics; Pediatric Anesthesia

Keywords

landmark; peripheral venous access; cephalic vein; vena cephalica; ultrasound-guided venipuncture; ultrasound-guided placement intravenous line

Outcome Measures

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.

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

Secondary Outcomes (6)

• 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)

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexander Schmidt: lead

Study Sites (1)

University Childrens Hospital, Department of Anaesthesia and Children's Research Centre

Zurich, Canton of Zurich, 8032, Switzerland

RECRUITING

Study Officials

• Alexander R Schmidt, MD

  University Children's Hospital, Zurich

  STUDY CHAIR

Central Study Contacts

Alexander R Schmidt, MD

CONTACT

+41 44 249 49 49; Alexander.Schmidt@kispi.uzh.ch

Robert J Herr, MD

CONTACT

+41 76 298 91 33; robert.herr@kispi.uzh.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Chief Department of Pediatric Anesthesia & Program Director for Research and Education, University Children's Hospital Zurich

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: January 12, 2026
• Study Start: January 6, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)