The Usefulness of Ultrasound Guided Technique Insertion of Radial Artery Catheter in Neonates and Infants

NCT ID: NCT02795468

Last Updated: 2018-04-26

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

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-02-28

Brief Summary

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The investigators are trying to compare the ultrasound-guided technique vs. palpation method for radial arterial cannulation in infants.

Detailed Description

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In infants (\<12mo), radial arterial catheterization is sometimes difficult to perform. Moreover, repeated attempts itself would cause the arterial spasm or hematoma. The use of ultrasound as an adjunct to radial arterial cannulation has considered to be the best practice in adults and pediatrics. However, its usefulness or superiority for neonates and infants is not known. Therefore, we would compare ultrasound guided radial arterial cannulation with the usual palpation methods in infants undergoing cardiac surgery.

Conditions

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Catheterization, Peripheral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Palpation group

The operator will use the pulsation of the radial artery as a guide for the cannulation.

Group Type ACTIVE_COMPARATOR

Radial arterial cannulation

Intervention Type PROCEDURE

Radial arterial cannulation using usual palpation method or ultrasound guided technique according to the group

Ultrasound group

The ultrasound guided technique will be used to find a radial artery and insert a radial arterial catheter.

Group Type EXPERIMENTAL

Radial arterial cannulation

Intervention Type PROCEDURE

Radial arterial cannulation using usual palpation method or ultrasound guided technique according to the group

Interventions

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Radial arterial cannulation

Radial arterial cannulation using usual palpation method or ultrasound guided technique according to the group

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Infants under 12 months age undergoing cardiac surgery with radial arterial cannulation

Exclusion Criteria

* Sign of a skin infection
* Wound near the puncture site
* abnormal circulation of the hand
* any vascular problem at radial or ulnar artery
Minimum Eligible Age

1 Day

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jong Hwan Lee

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jong Hwan Lee

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Huang HP, Zhao WJ, Wen F, Li XY. Application of ultrasound-guided radial artery cannulation in paediatric patients: A systematic review and meta-analysis. Aust Crit Care. 2021 Jul;34(4):388-394. doi: 10.1016/j.aucc.2020.09.001. Epub 2020 Oct 21.

Reference Type DERIVED
PMID: 33097369 (View on PubMed)

Min JJ, Tay CK, Gil NS, Lee JH, Kim S, Kim CS, Yang JH, Jun TG. Ultrasound-guided vs. palpation-guided techniques for radial arterial catheterisation in infants: A randomised controlled trial. Eur J Anaesthesiol. 2019 Mar;36(3):200-205. doi: 10.1097/EJA.0000000000000926.

Reference Type DERIVED
PMID: 30431501 (View on PubMed)

Other Identifiers

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2016-03-128-001

Identifier Type: -

Identifier Source: org_study_id

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