Central Venous Catheterization Techniques in Neonates

January 7, 2018 updated by: Jin-Tae Kim, Seoul National University Hospital

Randomized Controlled Trial on Central Venous Catheterization Techniques in Neonates: Seldinger Versus Modified Seldinger

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • surgery under general anesthesia
  • require central venous catheterization

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Seldinger
Use a 23 gauge introducer needle for ultrasound-guided central venous catheterization
Device: Ultrasound
Ultrasound-guided central venous catheterization in internal jugular vein
Other: General anesthesia
Scheduled operation under general anesthesia
Experimental: Modified Seldinger
Use a 22 gauge Angiocath Plus catheter for ultrasound-guided central venous catheterization
Device: Ultrasound
Ultrasound-guided central venous catheterization in internal jugular vein
Other: General anesthesia
Scheduled operation under general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
First successful central venous catheterization rate
Time Frame: Interval between skin penetration of the needle or angiocatheter and installation of the indwelling catheter, an expected average of 3 minutes
Interval between skin penetration of the needle or angiocatheter and installation of the indwelling catheter, an expected average of 3 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of central vein puncture trial
Time Frame: up to 5 times, an expected average observation time of 30 seconds
up to 5 times, an expected average observation time of 30 seconds
Number of guide wire insertion trial
Time Frame: up to 5 times, an expected average observation time of 90 seconds
up to 5 times, an expected average observation time of 90 seconds
First successful central vein puncture rate
Time Frame: Interval between skin penetration of the needle or angiocatheter and flashback of blood, an expected average of 30 seconds
Interval between skin penetration of the needle or angiocatheter and flashback of blood, an expected average of 30 seconds
Time to first puncture of central vein
Time Frame: Interval between skin penetration of the needle or angiocatheter and flashback of blood, an expected average of 30 seconds
Interval between skin penetration of the needle or angiocatheter and flashback of blood, an expected average of 30 seconds
Time to guide wire insertion
Time Frame: Interval between skin penetration and removal of the needle or angiocatheter after guide wire insertion, an expected average of 90 seconds
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
Time Frame: Interval between skin penetration of the needle or angiocatheter and installation of the indwelling catheter, an expected average of 3 minutes
Interval between skin penetration of the needle or angiocatheter and installation of the indwelling catheter, an expected average of 3 minutes
First successful guide wire insertion rate
Time Frame: Interval between skin penetration and removal of the needle or angiocatheter after guide wire insertion, an expected average of 90 seconds
Interval between skin penetration and removal of the needle or angiocatheter after guide wire insertion, an expected average of 90 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

February 17, 2016

First Submitted That Met QC Criteria

February 17, 2016

First Posted (Estimate)

February 23, 2016

Study Record Updates

Last Update Posted (Actual)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 7, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1601-108-736

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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