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OpenTrials
Completed

NCT Number: NCT03181542

Infra Red Vein Visualization: Efficacy vs. Standard Technique

The objective of the study is to assess the efficacy of the vein visualization device AccuVein (AccuVein, Inc., Huntington, NY) in comparison to a standard technique for establishing intravenous (iv) access in the infant and toddler population (<2years)

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Key information

Conditions

Difficult Intravenous Access

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

The objective of this project is to compare the iv success rate using the FDA approved Accuvein device for vein illumination versus not using the device, for infants/toddlers undergoing surgery at Penn State Children's Hospital with an ASA physical status 1, 2, or 3. After obtaining informed consent, the infant will be randomized to the vein illuminatin or standard group based on a computer generated number.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children(<2year) undergoing anesthesia procedures at Penn State Health, Hershey Medical Center and Penn State Children's Hospital
  • ASA physical status 1,2 or 3

Exclusion criteria

  • Emergency procedures requiring anesthesia
  • ASA physical status 4
  • Patients with pre existing iv access

Treatment and study plan

Infrared illumination

Device

Infrared illumination of veins using the FDA approved AccuVein (AccuVein, Inc., Huntington, NY) device.

Primary outcomes

  1. Success Rate

    Time frame: When patient is in operating room and insertion of intravenous access line has been confirmed to be successful, an average of 30 minutes

    Success for insertion of intravenous access line will be determined by flushability with 5 ml of sterile normal saline

Secondary outcomes

  1. The Number of Attempts

    Time frame: When patient is in operating room and insertion of intravenous access line is performed

    The number of attempts it takes for successful insertion of the intravenous access line

  2. Time to Successful Insertion

    Time frame: When patient is in operating room and insertion of intravenous access line is performed

    The time to successful insertion of the intravenous access line will be measured from the first time that the canula touches the skin to until successful iv access is established

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

A Randomized Controlled Study of Efficacy of Infra Red Vein Illumination Versus Standard Technique

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 8, 2017
Registry last updated
Dec 21, 2021

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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