Number of TrialsNCT02131519
Utility of Ultrasonography During Internal Jugular Vein Catheterisation in Pediatric Patients
An observational study of Number of Trials and Complication Rate, run by Ankara University at 2 sites in Turkey (Türkiye).
Trial summary
Central venous access may be essential in pediatric patients for fluid and a blood product administration, medication, parenteral nutrition, renal replacement therapy and hemodynamic monitoring. Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Number of Trials, Complication Rate
- What is being tested?
- internal jugular vein catheter placement
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Jan 2012to Mar 2014
- Phase
- Observational
- 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 month to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: pediatric patients aged more than 1 month
Who may be able to join
- pediatric patients required internal jugular vein catheter
Who cannot join
- aged smaller than 1 month
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ankara University, Pediatric Surgery
Ankara, 06550
Ankara University
Ankara, 06550
About this study
Central venous access may be essential in pediatric patients for fluid and a blood product administration, medication, parenteral nutrition, renal replacement therapy and hemodynamic monitoring. Obtaining central venous access in pediatric patients can be challenging, failure rates in pediatric patients range from 5% to 19% with reported complication rates from 2,5% to 22% The landmark technique has been standard approach for many years. In comparison with landmark method in pediatric patients the use of ultrasound is associated with an increased success rate decreased operative time, reduced number of cannulation attempts , and a decreased number of carotid artery punctures. We wanted to evaluate our success rate using ultrasound as a guidance during central vein insertion.
- Conditions
- Number of Trials, Complication Rate
- Being tested
- internal jugular vein catheter placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internal jugular vein catheter placementProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| internal jugular vein catheter | pediatric patients required internal jugular vein catheter Receives: Procedure: internal jugular vein catheter placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate
Measured: during anesthesia
Secondary outcomes (1)
complication rate
Measured: during anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startJan 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Number of TrialsStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CIGDEM YILDIRIM GUCLU, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131519
- Sponsor's protocol ID
- 13968
- Other IDs
- USG13968
- Status last verified
- May 2014
- First submitted
- 4 May 2014
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Ultrasonography During Internal Jugular Vein Catheterisation in Pediatric Patients
- ClinicalTrials.gov ID
- NCT02131519
- Acronym / sponsor ID
- 13968
- Conditions
- Number of Trials, Complication Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 6 May 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.
Central venous access may be essential in pediatric patients for fluid and a blood product administration, medication, parenteral nutrition, renal replacement therapy and hemodynamic monitoring. Obtaining central venous access in pediatric patients can be challenging, failure rates in pediatric patients range from 5% to 19% with reported complication rates from 2,5% to 22% The landmark technique has been standard approach for many years. In comparison with landmark method in pediatric patients the use of ultrasound is associated with an increased success rate decreased operative time, reduced number of cannulation attempts , and a decreased number of carotid artery punctures. We wanted to evaluate our success rate using ultrasound as a guidance during central vein insertion.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| internal jugular vein catheter | – | Procedure: internal jugular vein catheter placementpediatric patients required internal jugular vein catheter |
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- pediatric patients aged more than 1 month
Key inclusion criteria (1 listed)
- pediatric patients required internal jugular vein catheter
Key exclusion criteria (1 listed)
- aged smaller than 1 month
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 |
|---|---|---|
| internal jugular vein catheter placement | Procedure or surgery | internal jugular vein catheter |
Primary outcome
success rate
Time frame: during anesthesia
1 secondary outcome
complication rate
Time frame: during anesthesia
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 6 May 2014.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Number of Trials and Complication Rate, run by Ankara University at 2 sites in Turkey (Türkiye).
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 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 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
success rate (time frame: during anesthesia). 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 6 May 2014.