Ultrasound for Diagnosis of CVC Position in ChildrenCVCNCT02178423
Feasibility Study of CVC Diagnosis Via Ultrasound in Children
A study testing Ultrasound for diagnosis of CVC position in children in people with Ultrasound for Diagnosis of CVC Position in Children, run by Medical University of Vienna at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 8 years
- Conditions the study is for
- Ultrasound for Diagnosis of CVC Position in Children
- What is being tested?
- Ultrasound for diagnosis of CVC position in children
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Parents refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Ultrasound for diagnosis of CVC position in children
- Keywords
- children, ultrasound, central catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound for diagnosis of CVC position in childrenProcedure or surgery
Using the ultrasound for diagnosis of the correct position of a central venous catheter in children immediate after the puncture.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Experimental | Ultrasound for diagnosis of CVC position in children Receives: Procedure: Ultrasound for diagnosis of CVC position in children |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (1)
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.
Measured: At 30 to 60 minutes after central venous catheter insertion each participant will undergo chest ultrasound and chest X-ray.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound for Diagnosis of CVC Position in ChildrenStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Wolfgang Klug, Medical University of Vienna
- Investigators
- Georg Roth, Prof., Principal investigator, Dep. of Anesthesia and Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178423
- Sponsor's protocol ID
- 1059/2014
- Other IDs
- 1059/2014
- Acronym
- CVC
- Status last verified
- Jun 2015
- First submitted
- 11 Jun 2014
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Diagnosis of Central Venous Catheters in Children: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02178423
- Acronym / sponsor ID
- CVC / 1059/2014
- Keywords
- children, ultrasound, central catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Experimental | Procedure: Ultrasound for diagnosis of CVC position in childrenUltrasound for diagnosis of CVC position in children |
Who may qualify
- Ages
- 1 day to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Parents refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound for diagnosis of CVC position in childrenUsing the ultrasound for diagnosis of the correct position of a central venous catheter in children immediate after the puncture. | Procedure or surgery | Ultrasound |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georg Roth, Prof. principal investigator
Dep. of Anesthesia and Intensive Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound for diagnosis of CVC position in children in people with Ultrasound for Diagnosis of CVC Position in Children, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2015.