Complications Associated with Arterial Line Placement in Children

Not Applicable

Completed

• Conditions: Complications After Arterial Catheterization
• Interventions: Diagnostic Test: Ultrasonography

• Registration Number: NCT03784118
• Lead Sponsor: Seoul National University Hospital

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

Study Timeline

• Study First Submitted: 2018-12-11
• Study First Submitted QC: 2018-12-19
• Study First Posted: 2018-12-21
• Study Start: 2019-01-10
• Primary Completion: 2023-08-31
• Study Completion: 2023-09-02
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Children	Ultrasonography	Children who are followed up after arterial catheterization for evaluation of complications, using ultrasonography

Primary Outcome Measures

Name	Time	Method
Incidence of complications associated with arterial catheterization	within 5 days after 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.

Secondary Outcome Measures

Name	Time	Method
Time-dependent changes in perfusion index	from arterial catheterization to the end of surgery	Perfusion 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 factor	within 5 days after arterial catheterization	To 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 factor	within 5 days after arterial catheterization	To evaluate the number of attempts of arterial catheterization as one of the risk factors for complications
Duration of catheterization as a risk factor	within 5 days after arterial catheterization	To evaluate the duration of catheterization as one of the risk factors for complications

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of