Feasibility Study of CVC Diagnosis Via Ultrasound in Children

NCT ID: NCT02178423

Last Updated: 2015-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-06-30

Brief Summary

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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

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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.

Conditions

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Ultrasound for Diagnosis of CVC Position in Children

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Ultrasound

Ultrasound for diagnosis of CVC position in children

Group Type EXPERIMENTAL

Ultrasound for diagnosis of CVC position in children

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.


* 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
Minimum Eligible Age

1 Day

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Dr. Wolfgang Klug

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georg Roth, Prof.

Role: PRINCIPAL_INVESTIGATOR

Dep. of Anesthesia and Intensive Care Medicine

Locations

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Medical University of Vienna

Vienna, Vienna, Austria

Site Status

Countries

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Austria

Other Identifiers

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1059/2014

Identifier Type: OTHER

Identifier Source: secondary_id

1059/2014

Identifier Type: -

Identifier Source: org_study_id

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