Guidewire-assisted Radial A-line in Neonate and Infant
Comparison of Radial Artery Cannulation Technique in Pediatric Patients: Direct Versus Guidewire-assisted
1 other identifier
interventional
90
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2017
CompletedFirst Posted
Study publicly available on registry
July 13, 2017
CompletedStudy Start
First participant enrolled
August 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 4, 2018
CompletedApril 8, 2019
April 1, 2019
11 months
July 10, 2017
April 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
success rate at 1st attempt (%)
successful catheter insertion after obtaining 1st blood flush in angiocatheter.
from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
Secondary Outcomes (5)
total elapsed time (seconds)
from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
number of total cannulation attempts (number)
from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
number of total catheter used (number)
from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
malfunction of arterial line
from the start of invasive BP monitoring until the end of anesthesia (up to 1 day)
complications
from the arterial cannulation until the end of anesthesia (up to 1 day)
Study Arms (2)
Guidewire
EXPERIMENTAL1. Radial artery puncture with direct radial pulse palpation. 2. 24G angiocatheter insertion with guidewire-assist. (Catheter over guidewire)
Direct
ACTIVE COMPARATOR1. Radial artery puncture with direct radial pulse palpation. 2. 24G angiocatheter insertion without guidewire-assist. (Catheter over needle)
Interventions
Eligibility Criteria
You may qualify if:
- Pediatric patients undergoing general anesthesia with arterial cannulation (for hemodynamic monitoring or blood sampling)
You may not qualify if:
- Skin lesion, infection, hematoma, recent cannulation at cannulation site
- Unstable radial pulse (d/t unstable vital sign, or arrhythmias)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jin-Tae Kim
Seoul, South Korea
Related Publications (1)
Jang YE, Kim EH, Lee JH, Kim HS, Kim JT. Guidewire-assisted vs. direct radial arterial cannulation in neonates and infants: A randomised controlled trial. Eur J Anaesthesiol. 2019 Oct;36(10):738-744. doi: 10.1097/EJA.0000000000001064.
PMID: 31356376DERIVED
Study Officials
- STUDY CHAIR
Jin-Tae Kim, MD, PhD
Professor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 10, 2017
First Posted
July 13, 2017
Study Start
August 7, 2017
Primary Completion
July 4, 2018
Study Completion
July 4, 2018
Last Updated
April 8, 2019
Record last verified: 2019-04