Effect of Local Warming for Arterial Catheterization in Pediatric Anesthesia (WARM-PA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Congenital Heart Disease
• Intervention / Treatment: Procedure: local warming

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.

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hee Young Kim; Phone Number: +82-055-360-2129; Email: anekhy@pusan.ac.kr
• Study Contact Backup: Name: Seyeon Park; Phone Number: +82-055-360-2129; Email: chocostar@hanmail.net

Study Locations

• Korea, Republic of
  • Kyungnam
    • Yangsan, Kyungnam, Korea, Republic of, 50612
      • Recruiting
      • Pusan National University Yangsan Hospital
      • Contact: Seyeon Park; Phone Number: +82-055-360-2129; Email: chocostar@hanmail.net
      • Sub-Investigator: Seyeon Park

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; local warming on the site for arterial catheterization using forced air warmer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital
• Investigators: Principal Investigator: Hee Young Kim, Pusan National University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 8, 2023
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: 05-2023-183

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No