Complications Associated with Arterial Line Placement in Children
Study on Complications After Arterial Line Placement and the Risk Factors in Children
1 other identifier
interventional
82
1 country
1
Brief Summary
The purpose of this study is to find the risk factors for complications following arterial line catheterization. Ultrasonography is used to evaluate the size of artery which is cannulated, before and after catheterization. The complications include ischemia, bleeding, thrombosis and so on.
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 Jan 2019
Longer than P75 for not_applicable
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
December 11, 2018
CompletedFirst Posted
Study publicly available on registry
December 21, 2018
CompletedStudy Start
First participant enrolled
January 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 2, 2023
CompletedOctober 17, 2024
October 1, 2024
4.6 years
December 11, 2018
October 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of complications associated with arterial catheterization
Number of participants with complications following arterial catheterization. The complications include thrombus, ischemia, oozing or bleeding, and color change, etc. If any of these occur, it is assumed that complications have occurred.
within 5 days after arterial catheterization
Secondary Outcomes (4)
Time-dependent changes in perfusion index
from arterial catheterization to the end of surgery
Age as a risk factor
within 5 days after arterial catheterization
Number of attempts as a risk factor
within 5 days after arterial catheterization
Duration of catheterization as a risk factor
within 5 days after arterial catheterization
Study Arms (1)
Children
EXPERIMENTALChildren who are followed up after arterial catheterization for evaluation of complications, using ultrasonography
Interventions
Ultrasonography is used to evaluate the change in artery size after arterial catheterization and to assess the complication in children
measurement of perfusion index immediately after arterial catheterization until surgery end, in arterial catheterization site and contralateral site.
Eligibility Criteria
You may qualify if:
- Pediatric patients under 5 years of age who require invasive arterial pressure monitoring
You may not qualify if:
- Patients who do not need invasive arterial pressure monitoring
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, Seoul, 03080, South Korea
Related Publications (1)
Lee JH, Park JB, Ji SH, Jang YE, Kim EH, Kim JT, Kim HS. Immediate complications and risk factors following radial arterial catheterisation in paediatric patients at a tertiary centre. Eur J Anaesthesiol. 2025 Sep 8. doi: 10.1097/EJA.0000000000002268. Online ahead of print.
PMID: 40923190DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hee-Soo Kim Kim, PhD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 11, 2018
First Posted
December 21, 2018
Study Start
January 10, 2019
Primary Completion
August 31, 2023
Study Completion
September 2, 2023
Last Updated
October 17, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share