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NCT Number: NCT06041685

Effect of Local Warming for Arterial Catheterization in Pediatric Anesthesia

The increase in internal diameter (ID) and cross-sectional area (CSA) may facilitate better arterial catheterization. Since an increase in body temperature can cause peripheral vasodilation, we aimed to determine if local warming of the radial artery (RA) catheterization site could improve the success rate of catheterization in pediatric patients.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location status: Recruiting

Location contact

Seyeon Park

CONTACT

[email protected]

+82-055-360-2129

Seyeon Park

SUB_INVESTIGATOR

About this study

This randomized, controlled study enrolls 126 pediatric patients aged ≤ 2 years who were scheduled for heart surgery. They are randomized into non-warming (C) and warming (W) groups. After induction, the baseline artery ultrasonography images are collected. In the warming group (W), local warming is applied on the catheterization site. Before catheterization, the artery ultrasonography images are collected. The primary outcome is the first-attempt success rate. The secondary outcomes included the ID and CSA of the artery and overall complications.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • aged ≤ 2 years
  • cardiac surgery with peripheral artery catheterization

Exclusion criteria

  • unstable vital signs
  • pre-existing arterial catheter (exception of umbilical artery catheterization)

Treatment and study plan

local warming

Procedure

local warming on the site for arterial catheterization using forced air warmer

Primary outcomes

  1. first-attempt success rate of arterial catheterization

    Time frame: baseline, imediate after arterial catheterization

    The first-attempt success rate of pediatric peripheral arterial catheterization in the non-warming group, or warming group

Secondary outcomes

  1. internal diameter (ID) and cross-sectional area (CSA)

    Time frame: baseline, imediate after arterial catheterization in the non-warming group, or warming group

    internal diameter (ID) and cross-sectional area (CSA)

Study contacts

Contact information is provided by the study sponsor or research team.

Hee Young Kim

CONTACT

[email protected]

+82-055-360-2129

Seyeon Park

CONTACT

[email protected]

+82-055-360-2129

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

Effect of Local Warming for Arterial Catheterization in Pediatric Cardiac Surgery: A Prospective Randomized Controlled Study

Acronym: WARM-PA

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 18, 2023
Registry last updated
Aug 12, 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.

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