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Complications Associated with Arterial Line Placement in Children

Study on Complications After Arterial Line Placement and the Risk Factors in Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03784118
Enrollment
82
Registered
2018-12-21
Start date
2019-01-10
Completion date
2023-09-02
Last updated
2024-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications After Arterial Catheterization

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.

Detailed description

artery observation with ultrasound

Interventions

DIAGNOSTIC_TESTUltrasonography

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

DIAGNOSTIC_TESTperfusion index

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

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
No

Inclusion criteria

* Pediatric patients under 5 years of age who require invasive arterial pressure monitoring

Exclusion criteria

* Patients who do not need invasive arterial pressure monitoring

Design outcomes

Primary

MeasureTime frameDescription
Incidence of complications associated with arterial catheterizationwithin 5 days after arterial catheterizationNumber 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.

Secondary

MeasureTime frameDescription
Time-dependent changes in perfusion indexfrom arterial catheterization to the end of surgeryPerfusion index was continuously monitored throughout surgery, on both sides: the digit on the side of the arterial line placement and the opposite side
Age as a risk factorwithin 5 days after arterial catheterizationTo evaluate the age as one of the risk factors for complications following arterial catheterization using univariable logistic regression analysis.
Number of attempts as a risk factorwithin 5 days after arterial catheterizationTo evaluate the number of attempts of arterial catheterization as one of the risk factors for complications
Duration of catheterization as a risk factorwithin 5 days after arterial catheterizationTo evaluate the duration of catheterization as one of the risk factors for complications

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026