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Clinical Trials/NCT02806401
NCT02806401CompletedNot Applicable

Real-time Ultrasound-guided Axillary Venous Catheterization in Pediatric Patients: Comparison With the Landmark Technique Subclavian Vein Catheterization

Seoul National University Hospital1 site in 1 country132 target enrollmentStarted: June 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
132
Locations
1
Primary Endpoint
2nd access success rate

Study Overview

Brief 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.

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
1 Month to 7 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •surgery under general anesthesia require central venous catheterization

Exclusion Criteria

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

Arms & Interventions

landmark

Experimental

landmark method_subclavian venous cannulation

Intervention: landmark (Device)

US_Ax

Active Comparator

ultrasound guided axillary venous cannulation

Intervention: US_Ax (Device)

Outcomes

Primary Outcomes

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

  • 1st access success rate(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(interval between skin penetration and removal of the needle or catheter after central line insertion, an expected average of 120 seconds)
  • total time(interval between skin penetration and removal of the needle or catheter after central line insertion, an expected average of 120 seconds)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jin-Tae Kim

professor

Seoul National University Hospital

Study Sites (1)

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