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OpenTrials
Completed

NCT Number: NCT03784118

Complications Associated with Arterial Line Placement 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.

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Key information

Conditions

Complications After Arterial Catheterization

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

artery observation with ultrasound

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultrasonography

Diagnostic Test

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

Perfusion index

Diagnostic Test

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

Primary outcomes

  1. Incidence of complications associated with arterial catheterization

    Time frame: 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 outcomes

  1. Time-dependent changes in perfusion index

    Time frame: 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

  2. Age as a risk factor

    Time frame: 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.

  3. Number of attempts as a risk factor

    Time frame: within 5 days after arterial catheterization

    To evaluate the number of attempts of arterial catheterization as one of the risk factors for complications

  4. Duration of catheterization as a risk factor

    Time frame: within 5 days after arterial catheterization

    To evaluate the duration of catheterization as one of the risk factors for complications

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Dec 21, 2018
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.