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

NCT04811430 | Completed FDA Device

• 1 other identifier: P88008.0
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Catheter Related Complication

Keywords

Visualization; Needle Guidance; Midline Catheter; Emergency Department Nurse

Outcome Measures

Primary Outcomes (5)

• Insertion Success

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

  1 hour

• Insertion Time

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

  1 hour

• Backwalling Events

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

  1 hour

• Needle redirects

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

  1 hour

• Accuracy of Needle Placement

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

  1 hour

Secondary Outcomes (1)

• Self-reported subjective measurements

  1 hour

Study Arms (2)

Randomized Traditional

Randomized to traditional ultrasound guided peripheral insertion placement vs placement with Cue needle tracking technology

Device: Randomized Traditional; Device: Cue(TM) Needle Tracking Technology

Radomized Cue Needle Tracking technology

Randomized to traditional ultrasound guided peripheral insertion placement vs placement with Cue needle tracking technology

Device: Randomized Traditional; Device: Cue(TM) Needle Tracking Technology

Interventions

Randomized Traditional DEVICE

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

Also known as: Randomized Traditional Ultrasound method

Radomized Cue Needle Tracking technology; Randomized Traditional

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

Radomized Cue Needle Tracking technology; Randomized Traditional

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Emergency Department and Critical Care Nurses

You may qualify if:

• 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

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (1)

Austin Convention Center

Austin, Texas, 78652, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 23, 2021
• Study Start: October 14, 2019
• Primary Completion: October 14, 2019
• Study Completion: October 15, 2019
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)