Ultrasound Guided Central Venous CannulationNCT02806401
Ultrasound Guided Axillary Venous Cannulation in Pediatrics
A study testing landmark and US_Ax in people with Ultrasound Guided Central Venous Cannulation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this prospective randomized study was to compare landmark-subclavian venous access to ultrasound-guided axillary venous access when performed by pediatric anesthesiologists. Read more about this study
- Who is it for?
- Ages 1 month to 7 years
- Conditions the study is for
- Ultrasound Guided Central Venous Cannulation
- What is being tested?
- landmark and US_Ax
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2016to Aug 2017
- 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 month to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- surgery under general anesthesia require central venous catheterization
Who cannot join
- hematoma in central vein central vein anomaly catheterization site infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-time Ultrasound-guided Axillary Venous Catheterization in Pediatric Patients: Comparison With the Landmark Technique Subclavian Vein Catheterization
The purpose of this prospective randomized study was to compare landmark-subclavian venous access to ultrasound-guided axillary venous access when performed by pediatric anesthesiologists.
Read the detailed description
Objective: Subclavian vein catheterization may cause various complications. The investigators will compare the real-time ultrasound-guided axillary venous access vs. the landmark method- subclavian venous access in pediatric paticipants. (the needle insertion point of ultrasound-guided axillary venous is axillary vein. and the needle insertion point of landmark method is infraclavicular subclavian vein)
Design: Prospective randomized study.
Setting: Operating room of a tertiary medical center.
Interventions: The investigators will compare the ultrasound-guided axillary vein cannulation (66 paticipants) vs. the landmark method (66 pa- ticipants).
- Being tested
- landmark, US_Ax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
landmarkDevice
US_AxDevice
| Study group | Role | What they receive |
|---|---|---|
| landmark | Experimental | landmark method_subclavian venous cannulation Receives: Device: landmark |
| US_Ax | Active comparator | ultrasound guided axillary venous cannulation Receives: Device: US_Ax |
What is being measured
The primary outcome is the main question the study is designed to answer.
2nd access success rate
Measured: interval between skin penetration and removal of the needle or catheter after central line insertion, an expected average of 120 seconds
Secondary outcomes (3)
1st access success rate
Measured: interval between skin penetration and removal of the needle or catheter after central line insertion, an expected average of 120 seconds
3rd access success rate
Measured: interval between skin penetration and removal of the needle or catheter after central line insertion, an expected average of 120 seconds
total time
Measured: interval between skin penetration and removal of the needle or catheter after central line insertion, an expected average of 120 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound Guided Central Venous CannulationStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 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
- NCT02806401
- Sponsor's protocol ID
- H-1603-111-750
- Status last verified
- Sep 2018
- First submitted
- 16 Jun 2016
- Last updated
- 7 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Ultrasound-guided Axillary Venous Catheterization in Pediatric Patients: Comparison With the Landmark Technique Subclavian Vein Catheterization
- ClinicalTrials.gov ID
- NCT02806401
- Acronym / sponsor ID
- H-1603-111-750
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- May 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 20 Jun 2016 (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.
The purpose of this prospective randomized study was to compare landmark-subclavian venous access to ultrasound-guided axillary venous access when performed by pediatric anesthesiologists.
Detailed description
Objective: Subclavian vein catheterization may cause various complications. The investigators will compare the real-time ultrasound-guided axillary venous access vs. the landmark method- subclavian venous access in pediatric paticipants. (the needle insertion point of ultrasound-guided axillary venous is axillary vein. and the needle insertion point of landmark method is infraclavicular subclavian vein)
Design: Prospective randomized study.
Setting: Operating room of a tertiary medical center.
Interventions: The investigators will compare the ultrasound-guided axillary vein cannulation (66 paticipants) vs. the landmark method (66 pa- ticipants).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| landmark | Experimental | Device: landmarklandmark method_subclavian venous cannulation |
| US_Ax | Active comparator | Device: US_Axultrasound guided axillary venous cannulation |
Who may qualify
- Ages
- 1 month to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- surgery under general anesthesia require central venous catheterization
Key exclusion criteria (1 listed)
- hematoma in central vein central vein anomaly catheterization site infection
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 |
|---|---|---|
| landmark | Device | landmark |
| US_Ax | Device | US_Ax |
Primary outcome
2nd access success rate
Time frame: interval between skin penetration and removal of the needle or catheter after central line insertion, an expected average of 120 seconds
3 secondary outcomes
1st access success rate
Time frame: interval between skin penetration and removal of the needle or catheter after central line insertion, an expected average of 120 seconds
3rd access success rate
Time frame: interval between skin penetration and removal of the needle or catheter after central line insertion, an expected average of 120 seconds
total time
Time frame: interval between skin penetration and removal of the needle or catheter after central line insertion, an expected average of 120 seconds
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 7 Sep 2018.
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?
A study testing landmark and US_Ax in people with Ultrasound Guided Central Venous Cannulation, run by Seoul National University Hospital at 1 site in South Korea.
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 7 Sep 2018. 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 South Korea. 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?
2nd access success rate (time frame: interval between skin penetration and removal of the needle or catheter after central line insertion, an expected average of 120 seconds). 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 7 Sep 2018; AzTrials last refreshed its copy on 7 Nov 2026.