NCT02688595

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

1.4 years

First QC Date

February 17, 2016

Last Update Submit

January 7, 2018

Conditions

Catheterization, Central Venous

Keywords

Infant, NewbornUltrasonography

Outcome Measures

Primary Outcomes (1)

  • First successful central venous catheterization rate

    Interval between skin penetration of the needle or angiocatheter and installation of the indwelling catheter, an expected average of 3 minutes

Secondary Outcomes (7)

  • Time to first puncture of central vein

    Interval between skin penetration of the needle or angiocatheter and flashback of blood, an expected average of 30 seconds

  • Time to guide wire insertion

    Interval between skin penetration and removal of the needle or angiocatheter after guide wire insertion, an expected average of 90 seconds

  • Total time to central venous catheterization

    Interval between skin penetration of the needle or angiocatheter and installation of the indwelling catheter, an expected average of 3 minutes

  • Number of central vein puncture trial

    up to 5 times, an expected average observation time of 30 seconds

  • Number of guide wire insertion trial

    up to 5 times, an expected average observation time of 90 seconds

  • +2 more secondary outcomes

Study Arms (2)

Seldinger

EXPERIMENTAL

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

Device: UltrasoundOther: General anesthesia

Modified Seldinger

EXPERIMENTAL

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

Device: UltrasoundOther: General anesthesia

Interventions

UltrasoundDEVICE

Ultrasound-guided central venous catheterization in internal jugular vein

Modified SeldingerSeldinger
General anesthesiaOTHER

Scheduled operation under general anesthesia

Modified SeldingerSeldinger

Eligibility Criteria

Age1 Day - 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • surgery under general anesthesia
  • require central venous catheterization

You may not qualify if:

  • central vein anomaly
  • hematoma in central vein
  • catheterization site infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (3)

  • 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.

    PMID: 15121722BACKGROUND

  • 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.

    PMID: 26248059BACKGROUND

  • 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.

    PMID: 30442261DERIVED

MeSH Terms

Interventions

UltrasonographyAnesthesia, General

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisAnesthesiaAnesthesia and Analgesia

Study Officials

  • Jin-Tae Kim

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 17, 2016

First Posted

February 23, 2016

Study Start

March 1, 2016

Primary Completion

August 1, 2017

Study Completion

September 1, 2017

Last Updated

January 9, 2018

Record last verified: 2018-01

Locations

KR(1)