Anatomic AbnormalityNCT03604094
Ultrasound Measurement of RIJV in Patients Between 0-2 Years
An observational study of Anatomic Abnormality and Internal Jugular Vein, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
After obtaining parental consent ultrasonographic evaluation of right internal jugular vein will be performed in pediatric patients undergoing elective surgeries between 0-2 years of age. The patients for whom central venous catheterization is indicated will be included. Read more about this study
- Who is it for?
- Ages Up to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Anatomic Abnormality, Internal Jugular Vein, Neonates
- What is being tested?
- Ultrasonographic evaluation
- Type of treatment
- Surgery or procedure
- How many people
- 156 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2018to 1 Jul 2019
- 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 Up to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy 0-2 year-old patients undergoing elective surgery.
Who may be able to join
- 0-2 years Elective surgery Requirement for central venous cannulation
Who cannot join
- Congenital cardiovascular anomalies Emergency surgeries Previous cannulation or any intervention on the neck
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evaluation of Anatomical Variations and Dimensions of RIJV With Ultrasound in Pediatric Patients Between 0-2 Years
After obtaining parental consent ultrasonographic evaluation of right internal jugular vein will be performed in pediatric patients undergoing elective surgeries between 0-2 years of age. The patients for whom central venous catheterization is indicated will be included. The success rates and outcomes of catheterization will be recorded.
- Being tested
- Ultrasonographic evaluation
- Keywords
- central venous catheter, pediatrics, ultrasound imaging
- Medical subject headings
- Congenital Abnormalities, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic evaluationProcedure or surgery
Right internal jugular vein will be evaluated with ultrasound for anatomical variations and dimensions
| Study group | Role | What they receive |
|---|---|---|
| Group I | 0-1 month old newborns Receives: Procedure: Ultrasonographic evaluation | |
| Group II | 1 month-2 year-old pediatric patients Receives: Procedure: Ultrasonographic evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical variations and dimensions of right internal jugular vein
The central vein will be evaluated by ultrasound
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start1 Jul 2018
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic AbnormalityStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filiz Uzumcugil, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604094
- Sponsor's protocol ID
- Ultrasonography of RIJV
- Status last verified
- Feb 2020
- First submitted
- 19 Jul 2018
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Anatomical Variations and Dimensions of RIJV With Ultrasound in Pediatric Patients Between 0-2 Years
- ClinicalTrials.gov ID
- NCT03604094
- Acronym / sponsor ID
- Ultrasonography of RIJV
- Keywords
- central venous catheter, pediatrics, ultrasound imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 27 Jul 2018 (actual)
- 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 obtaining parental consent ultrasonographic evaluation of right internal jugular vein will be performed in pediatric patients undergoing elective surgeries between 0-2 years of age. The patients for whom central venous catheterization is indicated will be included. The success rates and outcomes of catheterization will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Procedure: Ultrasonographic evaluation0-1 month old newborns |
| Group II | – | Procedure: Ultrasonographic evaluation1 month-2 year-old pediatric patients |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy 0-2 year-old patients undergoing elective surgery.
Key inclusion criteria (1 listed)
- 0-2 years Elective surgery Requirement for central venous cannulation
Key exclusion criteria (1 listed)
- Congenital cardiovascular anomalies Emergency surgeries Previous cannulation or any intervention on the neck
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 |
|---|---|---|
| Ultrasonographic evaluationRight internal jugular vein will be evaluated with ultrasound for anatomical variations and dimensions | Procedure or surgery | Group I, Group II |
Primary outcome
Anatomical variations and dimensions of right internal jugular vein
Time frame: 1 year
The central vein will be evaluated by ultrasound
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 21 Feb 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anatomic Abnormality and Internal Jugular Vein, run by Hacettepe University at 1 site 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 21 Feb 2020. 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 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?
Anatomical variations and dimensions of right internal jugular vein (time frame: 1 year). 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 21 Feb 2020.