Guidewire-assisted Radial A-line in Neonate and Infant

April 5, 2019 updated by: Jin-Tae Kim, Seoul National University Hospital

Comparison of Radial Artery Cannulation Technique in Pediatric Patients: Direct Versus Guidewire-assisted

In neonate and infant, radial artery cannulation may be challenging and multiple attempts are required because of the small diameter.

The invastigators will compare the success rates of radial arterial cannulation with a guidewire-assisted technique and the direct technique in pediatric patient(<1yr).

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

90

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

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pediatric patients undergoing general anesthesia with arterial cannulation (for hemodynamic monitoring or blood sampling)

Exclusion Criteria:

  • Skin lesion, infection, hematoma, recent cannulation at cannulation site
  • Unstable radial pulse (d/t unstable vital sign, or arrhythmias)

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Guidewire
  1. Radial artery puncture with direct radial pulse palpation.
  2. 24G angiocatheter insertion with guidewire-assist. (Catheter over guidewire)
catheter insertion with guidewire-assist(catheter over guidewire)
Active Comparator: Direct
  1. Radial artery puncture with direct radial pulse palpation.
  2. 24G angiocatheter insertion without guidewire-assist. (Catheter over needle)
catheter insertion without guidewire assist(catheter over needle)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
success rate at 1st attempt (%)
Time Frame: from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
successful catheter insertion after obtaining 1st blood flush in angiocatheter.
from arterial cannulation to successful invasive BP monitoring (up to 1 hour)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total elapsed time (seconds)
Time Frame: from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
total time for successful cannulation.
from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
number of total cannulation attempts (number)
Time Frame: from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
number of total attempts until successful cannulation. (1 attempt = 1 blood flush)
from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
number of total catheter used (number)
Time Frame: from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
number of total catheter used until successful cannulation.
from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
malfunction of arterial line
Time Frame: from the start of invasive BP monitoring until the end of anesthesia (up to 1 day)
pressure monitoring, blood sampling
from the start of invasive BP monitoring until the end of anesthesia (up to 1 day)
complications
Time Frame: from the arterial cannulation until the end of anesthesia (up to 1 day)
hematoma, ischemia
from the arterial cannulation until the end of anesthesia (up to 1 day)

Collaborators and Investigators

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

Investigators

  • Study Chair: Jin-Tae Kim, MD, PhD, Professor

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.

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 (Actual)

August 7, 2017

Primary Completion (Actual)

July 4, 2018

Study Completion (Actual)

July 4, 2018

Study Registration Dates

First Submitted

July 10, 2017

First Submitted That Met QC Criteria

July 12, 2017

First Posted (Actual)

July 13, 2017

Study Record Updates

Last Update Posted (Actual)

April 8, 2019

Last Update Submitted That Met QC Criteria

April 5, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 1706-086-859

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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