Complications Associated with Arterial Line Placement in Children

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

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.

Study Overview

• Status: Completed
• Conditions: Complications After Arterial Catheterization
• Intervention / Treatment: Diagnostic test: Ultrasonography; Diagnostic test: perfusion index

Detailed Description

artery observation with ultrasound

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Children; Children who are followed up after arterial catheterization for evaluation of complications, using ultrasonography	Diagnostic test: Ultrasonography; Ultrasonography is used to evaluate the change in artery size after arterial catheterization and to assess the complication in children; Diagnostic test: perfusion index; measurement of perfusion index immediately after arterial catheterization until surgery end, in arterial catheterization site and contralateral site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age as a risk factor	To evaluate the age as one of the risk factors for complications following arterial catheterization using univariable logistic regression analysis.	within 5 days after arterial catheterization
Number of attempts as a risk factor	To evaluate the number of attempts of arterial catheterization as one of the risk factors for complications	within 5 days after arterial catheterization
Duration of catheterization as a risk factor	To evaluate the duration of catheterization as one of the risk factors for complications	within 5 days after arterial catheterization
Time-dependent changes in perfusion index	Perfusion index was continuously monitored throughout surgery, on both sides: the digit on the side of the arterial line placement and the opposite side	from arterial catheterization to the end of surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Hee-Soo Kim Kim, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2019
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): September 2, 2023

Study Registration Dates

• First Submitted: December 11, 2018
• First Submitted That Met QC Criteria: December 19, 2018
• First Posted (Actual): December 21, 2018

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: H1812-032-991

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No