Skip to main content
OpenTrials
Completed

NCT Number: NCT02178423

Feasibility Study of CVC Diagnosis Via Ultrasound in Children

After the placement of a central venous catheter in children, a routine chest X-ray will be performed in order to examine the correct position of the catheter. In this feasibility study the investigators intend to evaluate whether the ultrasound is as sufficient as the chest X-ray to verify the correct position of the central venous catheter in children with the purpose to prevent radiation on children in the future.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ultrasound for Diagnosis of CVC Position in Children

Age range

1 day–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

About this study

For punctures of a central vein in very small children, ultrasound is an useful tool which allows for exact examination of the relevant anatomy in order to visualize the target vessel, so as to facilitate the puncture in real-time. However, to ascertain the correct position of the central venous catheter (CVC), a chest X-ray is still the gold standard. The main disadvantage of the X-ray is the children's exposure to radiation. That's why the investigators intend to perform this study whether the ultrasound is as sufficient as the chest X-ray to verify the correct position of a central venous catheter in children.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants and children aged between 0 and 8 years requiring a central venous catheter. The planned sample size is 20 subjects. The indication for a CVC, will be determined by the attending physician.

Inclusion criteria

  • Infants (inclusive early and late preterm) and children aged between 0 and 8 years
  • Necessity of a central venous catheter
  • Written informed consent given by parents after being provided with detailed information about the nature, risks, and scope of the catheterization
  • No legal incapacity and/or other circumstances rendering the parents unable to understand the nature, scope and possible consequences of the catheterization

Exclusion criteria

  • Parents refusal

Treatment and study plan

Ultrasound for diagnosis of CVC position in children

Procedure

Using the ultrasound for diagnosis of the correct position of a central venous catheter in children immediate after the puncture.

Primary outcomes

  1. Diagnosis of the correct central venous catheter position.

    Time frame: After all patients have been included (three months), all clips of each participant will be presented to three blind observers, classifying these clips for two times and outcome measure will be assessed.

    Ultrasound imaging will be stored in mpeg format and deidentified for all examinations. The ultrasound movie will be split into five clips with a length of 5 seconds each (four clips with CVC not inserted but ultrasound head slightly moving and one clip with CVC in situ). The total of 110 clips is presented in random order to three blinded observers who classify these clips two times with a time gap of at least 2 weeks between the classifications.

Secondary outcomes

  1. Exclusion of a pneumothorax via ultrasound compared to chest X-ray

    Time frame: At 30 to 60 minutes after central venous catheter insertion each participant will undergo chest ultrasound and chest X-ray.

    The chest X-ray and ultrasound will be performed in the post anesthesia care unit to rule out a pneumothorax.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Ultrasound Guided Diagnosis of Central Venous Catheters in Children: A Feasibility Study

Acronym: CVC

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 30, 2014
Registry last updated
Jun 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.