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RecruitingNCT06041685WARM-PAUpdated Sep 16, 2026

Effect of Local Warming for Arterial Catheterization in Pediatric Anesthesia

An interventional study of local warming in Congenital Heart Disease, sponsored by Pusan National University Yangsan Hospital. Recruiting at 1 site in South Korea. Open to participants aged Up to 2 Years. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Pusan National University Yangsan Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
Up to 2 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Congenital Heart Disease
03

In context

Heart Defects, Congenital

991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.

This study's planned enrollment of 126 is above the median of 60 across 507 interventional studies indexed under Heart Defects, Congenital.

Browse Heart Defects, Congenital studies →

Lead sponsor

Pusan National University Yangsan Hospital is the lead sponsor of 108 studies on the registry; 27 are open to participants now.

Browse Pusan National University Yangsan Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 2 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • unstable vital signs
  • pre-existing arterial catheter (exception of umbilical artery catheterization)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
126 participants (estimated)

Study arms

  • No intervention
    Non-warming group (C)

    After induction, the baseline artery ultrasonography images are collected for the internal diameter and cross-sectional area of the artery. In the non-warming group (C), local warming is not applied on the catheterization site. Before catheterization, the artery ultrasonography images are collected. Then, arterial catheterization is applied.

  • Experimental
    Warming group (W)

    In the warming group (W), local warming is applied on the catheterization site. Before catheterization, the artery ultrasonography images are collected. Then, arterial catheterization is done.

    Procedure: local warming

Interventions

  • Procedurelocal warming

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

06

What researchers measure

Primary outcomes

  1. first-attempt success rate of arterial catheterization

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

    Time frame: baseline, imediate after arterial catheterization

Secondary outcomes

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

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

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

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. PubMed 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. PubMed 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. PubMed 16991588 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2023 (actual). Primary completion is estimated for Dec 2026, 39 months after the start.

Of 205 non-industry interventional studies with no phase under Heart Defects, Congenital, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 39 months is above that.

Counting every sponsor, half of 223 studies reached it within 34 months; a quarter within 17 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 8, 2023
First posted
Sep 18, 2023
StartActual
Sep 22, 2023
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06041685
Lead sponsor
Pusan National University Yangsan Hospital
Responsible party
Kim Hee Young (Fund assistant professor, Pusan National University Yangsan Hospital) — Principal investigator
First posted
Sep 18, 2023
Start date
Sep 22, 2023
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 16, 2026

Study contacts

Hee Young Kim
Contact
anekhy@pusan.ac.kr
+82-055-360-2129
Seyeon Park
Contact
chocostar@hanmail.net
+82-055-360-2129
Hee Young Kim
principal investigator · Pusan National University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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