Ultrasound Guided Axillary Venous Cannulation in Pediatrics

September 5, 2018 updated by: Jin-Tae Kim, Seoul National University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • surgery under general anesthesia require central venous catheterization

Exclusion Criteria:

  • hematoma in central vein central vein anomaly catheterization site infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: landmark
landmark method_subclavian venous cannulation
Device: landmark
Active Comparator: US_Ax
ultrasound guided axillary venous cannulation
Device: US_Ax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
interval between skin penetration and removal of the needle or catheter after central line insertion, an expected average of 120 seconds

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
interval between skin penetration and removal of the needle or catheter after central line insertion, an expected average of 120 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

June 16, 2016

First Submitted That Met QC Criteria

June 16, 2016

First Posted (Estimate)

June 20, 2016

Study Record Updates

Last Update Posted (Actual)

September 7, 2018

Last Update Submitted That Met QC Criteria

September 5, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • H-1603-111-750

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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