Effect of Local Warming for Arterial Catheterization in Pediatric Anesthesia

Congenital Heart Disease Clinical Trial

— WARM-PA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06041685
• Other study ID #: 05-2023-183
• Status: Recruiting
• Phase: N/A
• Start date: September 22, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Pusan National University Yangsan Hospital
• Contact: Hee Young Kim
• Phone: +82-055-360-2129
• Email: anekhy[@]pusan.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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)

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Kyungnam

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	internal diameter (ID) and cross-sectional area (CSA)	internal diameter (ID) and cross-sectional area (CSA)	baseline, imediate after arterial catheterization in the non-warming group, or warming group