Ultrasonography, Pediatrics, Overlap, Vascular StructuresNCT02217176
Ultrasonography of the Neck: The Influence of Airway Devices on Vascular Topography in Pediatric Patients
An observational study of Ultrasonography, Pediatrics, Overlap, Vascular Structures, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Internal jugular venous catheterization is a challenging procedure in pediatric patients due to small size. Overlapping of the internal jugular vein (IJV) and common carotid artery (CCA) may jeopardize the success and increase the complication rate.However, the use of ultrasound as an assistance tool might be helpful… Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Ultrasonography, Pediatrics, Overlap, Vascular Structures
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2011to Jan 2012
- 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: The pediatric population who were undergone any type of surgery under general anesthesia
Who may be able to join
- patients with American Society of Anesthesiologist status I-IV
Who cannot join
- patients with prior internal jugular vein catheterization or cardiovascular system anomaly
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Department of Anesthesiology and Intensive Care Medicine
Ankara, 06590
About this study
Internal jugular venous catheterization is a challenging procedure in pediatric patients due to small size. Overlapping of the internal jugular vein (IJV) and common carotid artery (CCA) may jeopardize the success and increase the complication rate.However, the use of ultrasound as an assistance tool might be helpful to identify the relationship between the IJV and the CCA. Endotracheal intubation and insertion of laryngeal mask are the common options for the airway management during general anesthesia for central venous catheterization. In this observational study, the investigators aimed to investigate the impact of the laryngeal mask insertion or endotracheal intubation and the role of head rotation on the overlap of the IJV and CCA evaluated with ultrasound in pediatric patients undergoing any kind of surgical procedure.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| endotracheal intubation | Not described | |
| laryngeal mask airway | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome is the overlap percentages (%) of right and left IJVs before and just after insertion of LMA compared with ETT. Overlap percentage is calculated as overlap of IJV(mm)/carotid artery diameter(mm))*100 obtained from ultrasonographic images.
The airway devices are identified according to the own preference of the responsible anesthesiologist regarding to the patient's status and the type of surgery.
Ultrasonographic images of each patient are recorded bilaterally with a 8-12 MHz linear probe (Venue 40 GE, USA) at the cricoid cartilage level perpendicular to the skin, parallel to mandibula in neutral, 40o and 80o head away position. The same ultrasonographic evaluations are repeated after the airway device insertion. The images are then evaluated by three different anesthesiologist.
Measured: Obtaining ultrasonographic images takes 30 minutes on average per patient
Secondary outcomes (1)
the relationship between IJV and CCA defined as anterior, anterolateral, lateral, anteromedial and medial according to the IJV's topographic location
Measured: Obtaining ultrasonographic images takes 30 minutes on average per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startMay 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasonography, Pediatrics, Overlap, Vascular StructuresStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Collaborators
- Harran University
- Responsible party
- Principal investigator, Menekse Ozcelik, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217176
- Sponsor's protocol ID
- 31-662
- Status last verified
- Aug 2014
- First submitted
- 10 Aug 2014
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonography of the Neck: The Influence of Airway Devices on Vascular Topography in Pediatric Patients
- ClinicalTrials.gov ID
- NCT02217176
- Acronym / sponsor ID
- 31-662
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- Harran University
- Study start
- May 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 15 Aug 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.
Internal jugular venous catheterization is a challenging procedure in pediatric patients due to small size. Overlapping of the internal jugular vein (IJV) and common carotid artery (CCA) may jeopardize the success and increase the complication rate.However, the use of ultrasound as an assistance tool might be helpful to identify the relationship between the IJV and the CCA. Endotracheal intubation and insertion of laryngeal mask are the common options for the airway management during general anesthesia for central venous catheterization. In this observational study, the investigators aimed to investigate the impact of the laryngeal mask insertion or endotracheal intubation and the role of head rotation on the overlap of the IJV and CCA evaluated with ultrasound in pediatric patients undergoing any kind of surgical procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endotracheal intubation | – | – |
| laryngeal mask airway | – | – |
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The pediatric population who were undergone any type of surgery under general anesthesia
Key inclusion criteria (1 listed)
- patients with American Society of Anesthesiologist status I-IV
Key exclusion criteria (1 listed)
- patients with prior internal jugular vein catheterization or cardiovascular system anomaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary outcome is the overlap percentages (%) of right and left IJVs before and just after insertion of LMA compared with ETT. Overlap percentage is calculated as overlap of IJV(mm)/carotid artery diameter(mm))*100 obtained from ultrasonographic images.
Time frame: Obtaining ultrasonographic images takes 30 minutes on average per patient
The airway devices are identified according to the own preference of the responsible anesthesiologist regarding to the patient's status and the type of surgery. Ultrasonographic images of each patient are recorded bilaterally with a 8-12 MHz linear probe (Venue 40 GE, USA) at the cricoid cartilage level perpendicular to the skin, parallel to mandibula in neutral, 40o and 80o head away position. The same ultrasonographic evaluations are repeated after the airway device insertion. The images are then evaluated by three different anesthesiologist.
1 secondary outcome
the relationship between IJV and CCA defined as anterior, anterolateral, lateral, anteromedial and medial according to the IJV's topographic location
Time frame: Obtaining ultrasonographic images takes 30 minutes on average per patient
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 15 Aug 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.
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 Ultrasonography, Pediatrics, Overlap, Vascular Structures, run by Ankara 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 15 Aug 2014. 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?
Primary outcome is the overlap percentages (%) of right and left IJVs before and just after insertion of LMA compared with ETT. Overlap percentage is calculated as overlap of IJV(mm)/carotid artery diameter(mm))*100 obtained from ultrasonographic images. (time frame: Obtaining ultrasonographic images takes 30 minutes on average per patient). 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 15 Aug 2014.