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Recruiting NCT06041685

Effect of Local Warming for Arterial Catheterization in Pediatric Anesthesia

No phase Interventional Congenital Heart Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: local warming.
Who it may be relevant to
Registry conditions: Congenital Heart Disease. Basic parameters: up to 2 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • first-attempt success rate of arterial catheterization [Time frame: baseline, imediate after arterial catheterization]
Secondary outcome measures (1)
  • internal diameter (ID) and cross-sectional area (CSA) [Time frame: baseline, imediate after arterial catheterization in the non-warming group, or warming group]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

South Korea · 1 center
  • Pusan National University Yangsan Hospital — Yangsan

Publications

  • Christen S, Delachaux A, Dischl B, Golay S, Liaudet L, Feihl F, Waeber B. Dose-dependent vasodilatory effects of acetylcholine and local warming on skin microcirculation. J Cardiovasc Pharmacol. 2004 Dec;44(6):659-64. doi: 10.1097/00005344-200412000-00006. PMID 15550784
  • Al-Hakim R, Hedge JC, Jahangiri Y, Kaufman JA, Galuppo R, Farsad K. Palmar Warming for Radial Artery Vasodilation to Facilitate Transradial Access: A Randomized Controlled Trial. J Vasc Interv Radiol. 2019 Mar;30(3):421-424. doi: 10.1016/j.jvir.2018.10.021. PMID 30819486
  • Barcroft H, Edholm OG. The effect of temperature on blood flow and deep temperature in the human forearm. J Physiol. 1943 Jun 30;102(1):5-20. doi: 10.1113/jphysiol.1943.sp004009. No abstract available. PMID 16991588

Identifiers

NCT: NCT06041685 · 05-2023-183

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗