Effect of Local Warming for Arterial Catheterization in Pediatric Anesthesia

NCT ID: NCT06041685

Last Updated: 2024-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-22

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Congenital Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

local warming

Intervention Type PROCEDURE

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

Interventions

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local warming

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pusan National University Yangsan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kim Hee Young

Fund assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hee Young Kim

Role: PRINCIPAL_INVESTIGATOR

Pusan National University

Locations

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Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hee Young Kim

Role: CONTACT

+82-055-360-2129

Seyeon Park

Role: CONTACT

+82-055-360-2129

Facility Contacts

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Seyeon Park

Role: primary

+82-055-360-2129

References

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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.

Reference Type BACKGROUND
PMID: 15550784 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30819486 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16991588 (View on PubMed)

Other Identifiers

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05-2023-183

Identifier Type: -

Identifier Source: org_study_id

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