Feasibility Study of CVC Diagnosis Via Ultrasound in Children (CVC)

June 8, 2015 updated by: Dr. Wolfgang Klug, Medical University of Vienna

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 8 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound
Ultrasound for diagnosis of CVC position in children
Procedure: Ultrasound for diagnosis of CVC position in children
Using the ultrasound for diagnosis of the correct position of a central venous catheter in children immediate after the puncture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 30 to 60 minutes after central venous catheter insertion each participant will undergo chest ultrasound and chest X-ray.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Georg Roth, Prof., Dep. of Anesthesia and Intensive Care Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 11, 2014

First Submitted That Met QC Criteria

June 27, 2014

First Posted (Estimate)

June 30, 2014

Study Record Updates

Last Update Posted (Estimate)

June 9, 2015

Last Update Submitted That Met QC Criteria

June 8, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1059/2014 (Other Identifier: Ethics committee Medical University of Vienna)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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