Clinical trial NCT02178423: Feasibility Study of CVC Diagnosis Via Ultrasound in Children
Official title: Ultrasound Guided Diagnosis of Central Venous Catheters in Children: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasound for Diagnosis of CVC Position in Children
Keywords: children, ultrasound, central catheter
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2014-06-30
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnosis of the correct central venous catheter position.
timeFrame: 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.
Secondary outcomes:
measure: Exclusion of a pneumothorax via ultrasound compared to chest X-ray
timeFrame: At 30 to 60 minutes after central venous catheter insertion each participant will undergo chest ultrasound and chest X-ray.
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Dep. of Anesthesia and Intensive Care Medicine
name: Georg Roth, Prof.
role: PRINCIPAL_INVESTIGATOR
References: