NCT06041685

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

September 22, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

2.3 years

First QC Date

September 8, 2023

Last Update Submit

August 9, 2024

Conditions

Congenital Heart Disease

Outcome Measures

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

    baseline, imediate after arterial catheterization

Secondary Outcomes (1)

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

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

Study Arms (2)

Non-warming group (C)

NO INTERVENTION

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.

Warming group (W)

EXPERIMENTAL

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

local warmingPROCEDURE

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

Warming group (W)

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

RECRUITING

Related Publications (3)

  • 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: 15550784BACKGROUND

  • 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: 30819486BACKGROUND

  • 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: 16991588BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Hee Young Kim

    Pusan National University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hee Young Kim

CONTACT

+82-055-360-2129anekhy@pusan.ac.kr

Seyeon Park

CONTACT

+82-055-360-2129chocostar@hanmail.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fund assistant professor

Study Record Dates

First Submitted

September 8, 2023

First Posted

September 18, 2023

Study Start

September 22, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

August 12, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)