NCT03784118

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 21, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

January 10, 2019

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2023

Completed
Last Updated

October 17, 2024

Status Verified

October 1, 2024

Enrollment Period

4.6 years

First QC Date

December 11, 2018

Last Update Submit

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

EXPERIMENTAL

Children who are followed up after arterial catheterization for evaluation of complications, using ultrasonography

Diagnostic Test: UltrasonographyDiagnostic Test: perfusion index

Interventions

UltrasonographyDIAGNOSTIC_TEST

Ultrasonography is used to evaluate the change in artery size after arterial catheterization and to assess the complication in children

Children
perfusion indexDIAGNOSTIC_TEST

measurement of perfusion index immediately after arterial catheterization until surgery end, in arterial catheterization site and contralateral site.

Children

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Location

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.

MeSH Terms

Interventions

UltrasonographyPerfusion Index

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Cardiovascular

Study Officials

  • Hee-Soo Kim Kim, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

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

Locations