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Completed

NCT Number: NCT02688595

Central Venous Catheterization Techniques in Neonates

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.

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Key information

Conditions

Catheterization, Central Venous

Age range

1 day–1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • surgery under general anesthesia
  • require central venous catheterization

Exclusion criteria

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

Treatment and study plan

Ultrasound

Device

Ultrasound-guided central venous catheterization in internal jugular vein

General anesthesia

Other

Scheduled operation under general anesthesia

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Number of central vein puncture trial

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

  5. Number of guide wire insertion trial

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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 23, 2016
Registry last updated
Jan 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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