Insertion Depth of Central Venous CatheterNCT01763229
The Practical Use of Transthoracic Echocardiography for Obtaining an Optimal Depth of Internal Jugular Venous Catheters in Infants
A study testing transthoracic echocardiography in people with Insertion Depth of Central Venous Catheter, run by Seoul National University Hospital.
Trial summary
To test if transthoracic echocardiography is useful for correct positioning of central venous catheters in infants with congenital heart disease Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Insertion Depth of Central Venous Catheter
- What is being tested?
- transthoracic echocardiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Mar 2013
- 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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- scheduled for surgery under general anesthesia
Who cannot join
- anomaly of the internal jugular vein
- thrombus in the internal jugular vein
About this study
To test if transthoracic echocardiography is useful for correct positioning of central venous catheters in infants with congenital heart disease
Read the detailed description
Patients scheduled for surgery for congenital heart disease younger than 12 months were studied. Following successful catheter insertion, the insertion depth was determined using transthoracic echocardiography. The long axis or short axis images were used.Chest X-ray images were taken postoperatively and distances from the tip to the carina level were measured.
- Being tested
- transthoracic echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transthoracic echocardiographyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| transthoracic echocardiography | Experimental | Not described Receives: Procedure: transthoracic echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
the distance between the catheter tip and the carina
Measured: After opearation (about 4-6 hour after insertion of the catheter)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2013 (estimated)
- Study startJan 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insertion Depth of Central Venous CatheterStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763229
- Sponsor's protocol ID
- H-1107-116-371
- Status last verified
- May 2014
- First submitted
- 5 Jan 2013
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Practical Use of Transthoracic Echocardiography for Obtaining an Optimal Depth of Internal Jugular Venous Catheters in Infants
- ClinicalTrials.gov ID
- NCT01763229
- Acronym / sponsor ID
- H-1107-116-371
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 8 Jan 2013 (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.
To test if transthoracic echocardiography is useful for correct positioning of central venous catheters in infants with congenital heart disease
Detailed description
Patients scheduled for surgery for congenital heart disease younger than 12 months were studied. Following successful catheter insertion, the insertion depth was determined using transthoracic echocardiography. The long axis or short axis images were used.Chest X-ray images were taken postoperatively and distances from the tip to the carina level were measured.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transthoracic echocardiography | Experimental | Procedure: transthoracic echocardiography |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- scheduled for surgery under general anesthesia
Key exclusion criteria (2 listed)
- anomaly of the internal jugular vein
- thrombus in the internal jugular vein
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 |
|---|---|---|
| transthoracic echocardiography | Procedure or surgery | transthoracic echocardiography |
Primary outcome
the distance between the catheter tip and the carina
Time frame: After opearation (about 4-6 hour after insertion of the catheter)
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 14 May 2014.
Related trials for Insertion Depth of Central Venous Catheter
Not yet recruitingObservational study
Efficacy and Safety of Peripherally Inserted Central Venous Catheters
Critical Illness, Catheter-Related Infections
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing transthoracic echocardiography in people with Insertion Depth of Central Venous Catheter, run by Seoul National University Hospital.
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 1 inclusion and 2 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 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
the distance between the catheter tip and the carina (time frame: After opearation (about 4-6 hour after insertion of the catheter)). 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 14 May 2014.