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

Sponsor
Pusan National University Yangsan Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06041685
Collaborator
(none)
126
1
2
15.5
8.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: local warming
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
126 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Effect of Local Warming for Arterial Catheterization in Pediatric Cardiac Surgery: A Prospective Randomized Controlled Study
Anticipated Study Start Date :
Sep 15, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. first-attempt success rate of arterial catheterization [baseline, imediate after arterial catheterization]

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

Secondary Outcome Measures

  1. internal diameter (ID) and cross-sectional area (CSA) [baseline, imediate after arterial catheterization in the non-warming group, or warming group]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 2 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pusan National University Yangsan Hospital Yangsan Kyungnam Korea, Republic of 50612

Sponsors and Collaborators

  • Pusan National University Yangsan Hospital

Investigators

  • Principal Investigator: Hee Young Kim, Pusan National University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Kim Hee Young, Fund assistant professor, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier:
NCT06041685
Other Study ID Numbers:
  • 2023-06-30
First Posted:
Sep 18, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2023