Actively Recruiting

Age: 0 - 5Years
All Genders
Healthy Volunteers
ID07333846

Development and Validation of a Landmark Formula for Distal Cephalic Vein Localization in Children Under 6 Years

Led by Alexander Schmidt ยท Updated on 2026-01-29

75

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating a new method to help locate a specific vein on the forearm (the distal cephalic vein) in young children undergoing surgery. This study focuses on children under six years old having elective procedures under general anesthesia. The goal is to find a simple, reliable anatomical landmark to guide the placement of a topical anesthetic patch (EMLA) to ease venipuncture, which can be challenging due to small or hard-to-see veins in young children. Ultrasound is used as a reference standard to validate the landmark's accuracy. The study has two parts: first, ultrasound is used to map and mark the vein's course on the skin during anesthesia, and photographic documentation is collected to develop the landmark. In the second part, anesthesia staff and parents apply the landmark or an EMLA patch guided by a visual instruction, and ultrasound checks if the vein lies beneath the marked or treated area. No additional needle punctures or blood samples are taken beyond routine care. Participants contribute data at one time point during their surgery preparation. Ultrasound measurements include whether the vein is under the marked area, vein depth, diameter, and course. Data are collected securely and pseudonymized. The study involves no added risks, no additional pain, and no biological samples. The main outcome is the success rate of locating the vein within the marked or EMLA-covered area during anesthesia.

CONDITIONS

Brief Title

A New Landmark-formula for Cephalic Vein in Children

Who Can Participate

Age: 0 - 5Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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)
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single time point

Participants undergo a single ultrasound examination after induction of general anesthesia during a planned surgery to assess the cephalic vein using the developed anatomical landmark and/or EMLA patch placement.

1 visit (in-person, during scheduled surgery)

Trial Site Locations

Total: 1 location

1

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

Zurich, Canton of Zurich, Switzerland, 8032

Actively Recruiting

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Research Team

A

Alexander R Schmidt, MD

R

Robert J Herr, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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