Ultrasound-guided Arterial Catheterization in Pediatric Patients

October 6, 2015 updated by: Jin-Tae Kim, Seoul National University Hospital

Comparison of Long-axis/In-plane and Short-axis/Out-of-plane Methods During the Ultrasound-guided Arterial Cannulation in Pediatric Patients

Investigators designed a prospective randomized controlled study to compare the long-axis/in-plane and short-axis/out-of-plane methods during the ultrasound-guided arterial catheterization in pediatric patients younger than 5 years old.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

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

No older than 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Surgery under general anesthesia
  • Requires invasive arterial blood pressure monitoring

Exclusion Criteria:

  • Infection/hematoma/skin disease/arteriovenous fistula/recent catheterization scar in radial artery or posterior tibial artery
  • Peripheral vascular disease
  • Congenital aortic disease

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Infant
Radial artery or posterior tibial artery of patients younger than 1 year old are either cannulated with short-axis/out-of-plane or long-axis/in-plane US-guided arterial catheterization technique.
Other: Long-axis/in-plane US-guided arterial catheterization
Cannulate the radial artery or posterior tibial artery of an infant of a preschool child putting the 24 gauge needle parallel to the ultrasound transducer.
Other: Short-axis/out-of-plane US-guided arterial catheterization
Cannulate the radial artery or posterior tibial artery of an infant or a preschool child putting the 24 gauge needle perpendicular to the ultrasound transducer.
Experimental: Preschool child
Radial artery or posterior tibial artery of patients older than 1 year old and younger than 5 years old are either cannulated with long-axis/in-plane or short-axis/out-of-plane US-guided arterial catheterization technique.
Other: Long-axis/in-plane US-guided arterial catheterization
Cannulate the radial artery or posterior tibial artery of an infant of a preschool child putting the 24 gauge needle parallel to the ultrasound transducer.
Other: Short-axis/out-of-plane US-guided arterial catheterization
Cannulate the radial artery or posterior tibial artery of an infant or a preschool child putting the 24 gauge needle perpendicular to the ultrasound transducer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Arterial catheterization time
Time Frame: Interval between contact of the ultrasound transducer with the skin and confirmation of an arterial waveform on the monitor, an expected average of 200 seconds
Interval between contact of the ultrasound transducer with the skin and confirmation of an arterial waveform on the monitor, an expected average of 200 seconds

Secondary Outcome Measures

Outcome Measure
Time Frame
Ultrasound imaging time
Time Frame: Interval between contact of the ultrasound transducer with the skin and penetration of the needle through the skin, an expected average of 30 seconds
Interval between contact of the ultrasound transducer with the skin and penetration of the needle through the skin, an expected average of 30 seconds
Time to first puncture of the artery
Time Frame: Interval between skin penetration of the needle and flashback of blood, an expected average of 100 seconds
Interval between skin penetration of the needle and flashback of blood, an expected average of 100 seconds
Number of puncture attempts
Time Frame: Up to 5 times, an expected average observation time of 600 seconds
Up to 5 times, an expected average observation time of 600 seconds

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jin-Tae Kim, MD. PhD., Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2015

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

January 5, 2015

First Submitted That Met QC Criteria

January 5, 2015

First Posted (Estimate)

January 7, 2015

Study Record Updates

Last Update Posted (Estimate)

October 7, 2015

Last Update Submitted That Met QC Criteria

October 6, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • H-1409-095-610

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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