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Completed

NCT Number: NCT01924975

Saphenous Vein Cannulation in Infants and Small Children

The purpose of this study is to compare the two different saphenous vein cannulation techniques; real-time ultrasound image-guided technique (Ultrasound group) vs. traditional landmark technique (Landmark group).

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Key information

Conditions

Saphenous Vein Cannulation

Age range

Up to 4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pediatric patient undergoing scheduled surgery which requires venous cannulation.
  • Term neonates and children < 4 years old weighing >/= 3 kg

Exclusion criteria

  • Patient with visible saphenous vein
  • Patient with no detectable saphenous vein under ultrasound
  • Patient with a skin wound or infection around puncture site
  • Patient with recent venous puncture at the puncture site (less than 1 month)
  • Patient with thrombus in saphenous vein or hematoma formation around the vein detected by ultrasound.
  • Patient with any emergency surgery

Treatment and study plan

Saphenous vein cannulation

Procedure

Intravenous cannulation to saphenous vein

ultrasound with a linear transducer (L15-7io)

Device

Portable, bed-side ultrasound to detect saphenous vein

A 22 or 24 G intravenous catheter

Device

Primary outcomes

  1. Percentage of Participants With First Attempt Success of Saphenous Vein Cannulation

    Time frame: 10 minutes

Secondary outcomes

  1. Percentage of Participants With Success of Saphenous Vein Cannulation Within 3 Attempts of Needle Insertion, or a 10 Minute Time Period.

    Time frame: 10 minutes

  2. Time Required for Overall Successful Venous Cannulation.

    Time frame: 10 minutes

Sponsors and collaborators

Lead sponsor

Satoshi Hanada

Other

Registry information

Official study title

Ultrasound-image Guided Versus Traditional Landmark Technique for Saphenous Vein Cannulation in Infants and Small Children

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 19, 2013
Registry last updated
Jan 23, 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.