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

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ClinicalTrials.gov Identifier: NCT04811430
Recruitment Status : Completed
First Posted : March 23, 2021
Last Update Posted : March 23, 2021
Sponsor:
Information provided by (Responsible Party):
Becton, Dickinson and Company

Study Description
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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.

Condition or disease Intervention/treatment
Catheter Related Complication 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 Design
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Study Type : Observational
Actual Enrollment : 49 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Comparative Effectiveness, Efficiency, and Emergency Department Nurse Preference Between 2 Methods of Visualization for Midline Catheter Insertion: A Pilot Study
Actual Study Start Date : October 14, 2019
Actual Primary Completion Date : October 14, 2019
Actual Study Completion Date : October 15, 2019
Groups and Cohorts
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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 Name: 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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Emergency Department and Critical Care Nurses
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04811430


Locations
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United States, Texas
Austin Convention Center
Austin, Texas, United States, 78652
Sponsors and Collaborators
Becton, Dickinson and Company
More Information
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Responsible Party: Becton, Dickinson and Company
ClinicalTrials.gov Identifier: NCT04811430    
Other Study ID Numbers: P88008.0
First Posted: March 23, 2021    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Becton, Dickinson and Company:
Visualization
Needle Guidance
Midline Catheter
Emergency Department Nurse
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes