The Usefulness of Ultrasound Guided Technique Insertion of Radial Artery Catheter in Neonates and Infants

April 24, 2018 updated by: Jong Hwan Lee, Samsung Medical Center
The investigators are trying to compare the ultrasound-guided technique vs. palpation method for radial arterial cannulation in infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In infants (<12mo), radial arterial catheterization is sometimes difficult to perform. Moreover, repeated attempts itself would cause the arterial spasm or hematoma. The use of ultrasound as an adjunct to radial arterial cannulation has considered to be the best practice in adults and pediatrics. However, its usefulness or superiority for neonates and infants is not known. Therefore, we would compare ultrasound guided radial arterial cannulation with the usual palpation methods in infants undergoing cardiac surgery.

Study Type

Interventional

Enrollment (Actual)

86

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 day to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Infants under 12 months age undergoing cardiac surgery with radial arterial cannulation

Exclusion Criteria:

  • Sign of a skin infection
  • Wound near the puncture site
  • abnormal circulation of the hand
  • any vascular problem at radial or ulnar artery

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Palpation group
The operator will use the pulsation of the radial artery as a guide for the cannulation.
Procedure: Radial arterial cannulation
Radial arterial cannulation using usual palpation method or ultrasound guided technique according to the group
Experimental: Ultrasound group
The ultrasound guided technique will be used to find a radial artery and insert a radial arterial catheter.
Procedure: Radial arterial cannulation
Radial arterial cannulation using usual palpation method or ultrasound guided technique according to the group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
First-pass success rate
Time Frame: Within 10 min from the start time of arterial cannulation using an angiocath
Within 10 min from the start time of arterial cannulation using an angiocath

Collaborators and Investigators

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

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Jong Hwan Lee, Samsung Medical Center

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

June 1, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 28, 2017

Study Registration Dates

First Submitted

May 26, 2016

First Submitted That Met QC Criteria

June 9, 2016

First Posted (Estimate)

June 10, 2016

Study Record Updates

Last Update Posted (Actual)

April 26, 2018

Last Update Submitted That Met QC Criteria

April 24, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2016-03-128-001

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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