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

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

Study Overview

• Status: Completed
• Conditions: Catheter Related Complication
• Intervention / Treatment: Device: Randomized Traditional; Device: Cue(TM) Needle Tracking Technology

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 Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78652
      • Austin Convention Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Emergency Department and Critical Care Nurses

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Randomized Traditional; Randomized to traditional ultrasound guided peripheral insertion placement vs placement with Cue needle tracking technology	Device: Randomized Traditional; Traditional ultrasound guidance was utilized to insert Midlines on simulated veins blocks not live patients; Other Names: Randomized Traditional Ultrasound method; Device: Cue(TM) Needle Tracking Technology; 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 to traditional ultrasound guided peripheral insertion placement vs placement with Cue needle tracking technology	Device: Randomized Traditional; Traditional ultrasound guidance was utilized to insert Midlines on simulated veins blocks not live patients; Other Names: Randomized Traditional Ultrasound method; Device: Cue(TM) Needle Tracking Technology; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported subjective measurements	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	1 hour

Collaborators and Investigators

• Sponsor: Becton, Dickinson and Company

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2019
• Primary Completion (Actual): October 14, 2019
• Study Completion (Actual): October 15, 2019

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Visualization; Needle Guidance; Midline Catheter; Emergency Department Nurse
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: P88008.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No