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CompletedNCT02806401Updated Sep 7, 2018

Ultrasound Guided Axillary Venous Cannulation in Pediatrics

An interventional study of landmark and US_Ax in Ultrasound Guided Central Venous Cannulation, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 1 Month to 7 Years. Per ClinicalTrials.gov, last updated 2018-09-07.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
1 Month to 7 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • Ultrasound Guided Central Venous Cannulation
03

In context

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • surgery under general anesthesia require central venous catheterization

Exclusion criteria

Exclusion Criteria:

  • hematoma in central vein central vein anomaly catheterization site infection
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
132 participants (actual)

Study arms

  • Experimental
    landmark

    landmark method_subclavian venous cannulation

    Device: landmark

  • Active comparator
    US_Ax

    ultrasound guided axillary venous cannulation

    Device: US_Ax

Interventions

  • Devicelandmark
  • DeviceUS_Ax
06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

07

Study locations

1 site
  • Jin-Tae Kim
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02806401
Lead sponsor
Seoul National University Hospital
Responsible party
Jin-Tae Kim (professor, Seoul National University Hospital) — Principal investigator
First posted
Jun 20, 2016
Start date
Jun 2016
Primary completion
May 2017
Completion
Aug 2017
Last update
Sep 7, 2018
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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