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

Completed

• Conditions: Catheter Related Complication
• Interventions: Device: Randomized Traditional; Device: Cue(TM) Needle Tracking Technology

• Registration Number: NCT04811430
• Lead Sponsor: Becton, Dickinson and Company

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.

Detailed Description

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.

Study Timeline

• Study Start: 2019-10-14
• Primary Completion: 2019-10-14
• Study Completion: 2019-10-15
• Status Verified: 2021-03
• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-19
• Last Update Submitted: 2021-03-19
• Study First Posted: 2021-03-23
• Last Update Posted: 2021-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

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Exclusion Criteria

• Nurses that don't meet that predetermined inclusion criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Radomized Cue Needle Tracking technology	Cue(TM) Needle Tracking Technology	Randomized to traditional ultrasound guided peripheral insertion placement vs placement with Cue needle tracking technology
Randomized Traditional	Randomized Traditional	Randomized to traditional ultrasound guided peripheral insertion placement vs placement with Cue needle tracking technology
Randomized Traditional	Cue(TM) Needle Tracking Technology	Randomized to traditional ultrasound guided peripheral insertion placement vs placement with Cue needle tracking technology
Radomized Cue Needle Tracking technology	Randomized Traditional	Randomized to traditional ultrasound guided peripheral insertion placement vs placement with Cue needle tracking technology

Primary Outcome Measures

Name	Time	Method
Insertion Success	1 hour	Number of attempts required to properly place a needle tip in the simulated vessel
Insertion Time	1 hour	Time required to successfully insert a needle tip into a simulated vessel
Backwalling Events	1 hour	Events where the needle fully transects the simulated blood vessel during the inserting of the needle tip into a simulated vessel
Needle redirects	1 hour	Lateral movement and deflection of the needle tip during insertion into a simulated vessel
Accuracy of Needle Placement	1 hour	Accuracy of needle placement as indicated by the lateral distance from a target

Secondary Outcome Measures

Name	Time	Method
Self-reported subjective measurements	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

Trial Locations

Locations (1)

Austin Convention Center; 🇺🇸 Austin, Texas, United States