Ultrasound for Diagnosis of CVC Position in Children Clinical Trial
— CVCOfficial title:
Ultrasound Guided Diagnosis of Central Venous Catheters in Children: A Feasibility Study
| Verified date | June 2015 |
| Source | Medical University of Vienna |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Austria: Ethikkommission |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | June 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 8 Years |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medical University of Vienna | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Vienna |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Diagnosis of the correct central venous catheter position. | 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. | 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. | Yes |
| Secondary | Exclusion of a pneumothorax via ultrasound compared to chest X-ray | The chest X-ray and ultrasound will be performed in the post anesthesia care unit to rule out a pneumothorax. | At 30 to 60 minutes after central venous catheter insertion each participant will undergo chest ultrasound and chest X-ray. | Yes |