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

Primary Purpose

Congenital Heart Disease

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
local warming
Sponsored by
Pusan National University Yangsan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Congenital Heart Disease

Eligibility Criteria

undefined - 2 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Pusan National University Yangsan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Non-warming group (C)

Warming group (W)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 8, 2023
Last Updated
September 23, 2023
Sponsor
Pusan National University Yangsan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06041685
Brief Title
Effect of Local Warming for Arterial Catheterization in Pediatric Anesthesia
Acronym
WARM-PA
Official Title
Effect of Local Warming for Arterial Catheterization in Pediatric Cardiac Surgery: A Prospective Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-warming group (C)
Arm Type
No Intervention
Arm Description
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.
Arm Title
Warming group (W)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
local warming
Intervention Description
local warming on the site for arterial catheterization using forced air warmer
Primary Outcome Measure Information:
Title
first-attempt success rate of arterial catheterization
Description
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 Outcome Measure Information:
Title
internal diameter (ID) and cross-sectional area (CSA)
Description
internal diameter (ID) and cross-sectional area (CSA)
Time Frame
baseline, imediate after arterial catheterization in the non-warming group, or warming group

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hee Young Kim
Phone
+82-055-360-2129
Email
anekhy@pusan.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Seyeon Park
Phone
+82-055-360-2129
Email
chocostar@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee Young Kim
Organizational Affiliation
Pusan National University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Kyungnam
ZIP/Postal Code
50612
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seyeon Park
Phone
+82-055-360-2129
Email
chocostar@hanmail.net
First Name & Middle Initial & Last Name & Degree
Seyeon Park

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15550784
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.
Results Reference
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PubMed Identifier
30819486
Citation
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.
Results Reference
background
PubMed Identifier
16991588
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.
Results Reference
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Effect of Local Warming for Arterial Catheterization in Pediatric Anesthesia

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