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

Catheter Related Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04811430
• Other study ID #: P88008.0
• Status: Completed
• Start date: October 14, 2019
• Est. completion date: October 15, 2019

Study information

• Verified date: March 2021
• Source: Becton, Dickinson and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: October 15, 2019
• Est. primary completion date: October 14, 2019
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Catheter Related Complication
• Emergencies

Intervention

Device:
• Randomized Traditional
Traditional ultrasound guidance was utilized to insert Midlines on simulated veins blocks not live patients
• 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

Locations

Country	Name	City	State
United States	Austin Convention Center	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Becton, Dickinson and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insertion Success	Number of attempts required to properly place a needle tip in the simulated vessel	1 hour
Primary	Insertion Time	Time required to successfully insert a needle tip into a simulated vessel	1 hour
Primary	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
Primary	Needle redirects	Lateral movement and deflection of the needle tip during insertion into a simulated vessel	1 hour
Primary	Accuracy of Needle Placement	Accuracy of needle placement as indicated by the lateral distance from a target	1 hour
Secondary	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