Central Venous Catheterization Techniques in Neonates

NCT ID: NCT02688595

Last Updated: 2018-01-09

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-09-30

Brief Summary

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The purpose of this study is to compare the differences in central venous catheter insertion time, success rate, and complication between the Seldinger and modified Seldinger technique for ultrasound-guided central venous catheterization in neonates.

Detailed Description

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Conditions

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Catheterization, Central Venous

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Seldinger

Use a 23 gauge introducer needle for ultrasound-guided central venous catheterization

Group Type EXPERIMENTAL

Ultrasound

Intervention Type DEVICE

Ultrasound-guided central venous catheterization in internal jugular vein

General anesthesia

Intervention Type OTHER

Scheduled operation under general anesthesia

Modified Seldinger

Use a 22 gauge Angiocath Plus catheter for ultrasound-guided central venous catheterization

Group Type EXPERIMENTAL

Ultrasound

Intervention Type DEVICE

Ultrasound-guided central venous catheterization in internal jugular vein

General anesthesia

Intervention Type OTHER

Scheduled operation under general anesthesia

Interventions

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Ultrasound

Ultrasound-guided central venous catheterization in internal jugular vein

Intervention Type DEVICE

General anesthesia

Scheduled operation under general anesthesia

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* surgery under general anesthesia
* require central venous catheterization

Exclusion Criteria

* central vein anomaly
* hematoma in central vein
* catheterization site infection
Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jin-Tae Kim

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin-Tae Kim

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Grebenik CR, Boyce A, Sinclair ME, Evans RD, Mason DG, Martin B. NICE guidelines for central venous catheterization in children. Is the evidence base sufficient? Br J Anaesth. 2004 Jun;92(6):827-30. doi: 10.1093/bja/aeh134. Epub 2004 Apr 30.

Reference Type BACKGROUND
PMID: 15121722 (View on PubMed)

Song IK, Lee JH, Kang JE, Oh HW, Kim HS, Park HP, Kim JT. Comparison of central venous catheterization techniques in pediatric patients: needle vs angiocath. Paediatr Anaesth. 2015 Nov;25(11):1120-6. doi: 10.1111/pan.12726. Epub 2015 Aug 6.

Reference Type BACKGROUND
PMID: 26248059 (View on PubMed)

Song IK, Kim EH, Lee JH, Jang YE, Kim HS, Kim JT. Seldinger vs modified Seldinger techniques for ultrasound-guided central venous catheterisation in neonates: a randomised controlled trial. Br J Anaesth. 2018 Dec;121(6):1332-1337. doi: 10.1016/j.bja.2018.08.008. Epub 2018 Sep 7.

Reference Type DERIVED
PMID: 30442261 (View on PubMed)

Other Identifiers

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1601-108-736

Identifier Type: -

Identifier Source: org_study_id

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