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Completed

NCT Number: NCT04811430

Efficiency, and Emergency Department Nurse Preference Between 2 Methods of Visualization: A Pilot Study

The purpose of this study was to assess the impact of a continuous needle tracking system on the accuracy, speed, and quality of ultrasound-guided peripheral venous catheter insertion.

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Key information

Conditions

Catheter Related Complication

Sex eligibility

All sexes

Study type

Observational

Primary location

Austin Convention Center

Austin, Texas, 78652, United States

About this study

A pilot study using simulated tissue was conducted with 49 US-based emergency department nurses to compare insertion of a midline catheter using traditional ultrasound guidance versus an advanced needle-tracking technology along with traditional ultrasound guidance.

Who can participate

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

Inclusion criteria

  • US-based emergency department nurse who have placed 10 peripheral intravenous catheters in the past 60 days
  • have placed less than or equal to 15 ultrasound-assisted vascular access devices in the past 60 days and have been practicing ultrasound-assisted vascular access no more than 18 months

Exclusion criteria

  • Nurses that don't meet that predetermined inclusion criteria

Treatment and study plan

Randomized Traditional

Device

Traditional ultrasound guidance was utilized to insert Midlines on simulated veins blocks not live patients

Other names: Randomized Traditional Ultrasound method

Cue(TM) Needle Tracking Technology

Device

Cue(TM) Needle Tracking Technology with real time needle tip tracking is used to assist ultrasound guided midline insertions on simulated veins blocks not live patients

Primary outcomes

  1. Insertion Success

    Time frame: 1 hour

    Number of attempts required to properly place a needle tip in the simulated vessel

  2. Insertion Time

    Time frame: 1 hour

    Time required to successfully insert a needle tip into a simulated vessel

  3. Backwalling Events

    Time frame: 1 hour

    Events where the needle fully transects the simulated blood vessel during the inserting of the needle tip into a simulated vessel

  4. Needle redirects

    Time frame: 1 hour

    Lateral movement and deflection of the needle tip during insertion into a simulated vessel

  5. Accuracy of Needle Placement

    Time frame: 1 hour

    Accuracy of needle placement as indicated by the lateral distance from a target

Secondary outcomes

  1. Self-reported subjective measurements

    Time frame: 1 hour

    Post-study questions were used to assess confidence during insertion with Cue needle tracking system (likert), confidence when insertion with traditional ultrasound techniques (likert), preference between the cue needle tracking system and the standard of care

Sponsors and collaborators

Lead sponsor

Becton, Dickinson and Company

Industry

Registry information

Official study title

Comparative Effectiveness, Efficiency, and Emergency Department Nurse Preference Between 2 Methods of Visualization for Midline Catheter Insertion: A Pilot Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 23, 2021
Registry last updated
Mar 23, 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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