Feasibility Study of CVC Diagnosis Via Ultrasound in Children

Not Applicable

Completed

• Conditions: Ultrasound for Diagnosis of CVC Position in Children
• Interventions: Procedure: Ultrasound for diagnosis of CVC position in children

• Registration Number: NCT02178423
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-11
• Study First Submitted QC: 2014-06-27
• Study First Posted: 2014-06-30
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2015-06-08
• Last Update Posted: 2015-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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Exclusion Criteria

• Parents refusal

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound	Ultrasound for diagnosis of CVC position in children	Ultrasound for diagnosis of CVC position in children

Primary Outcome Measures

Name	Time	Method
Diagnosis of the correct central venous catheter position.	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 Outcome Measures

Name	Time	Method
Exclusion of a pneumothorax via ultrasound compared to chest X-ray	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.

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria