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
NCT number | NCT04811430 |
Other study ID # | P88008.0 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 14, 2019 |
Est. completion date | October 15, 2019 |
Verified date | March 2021 |
Source | Becton, Dickinson and Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 49 |
Est. completion date | October 15, 2019 |
Est. primary completion date | October 14, 2019 |
Accepts healthy volunteers | |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Austin Convention Center | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
Becton, Dickinson and Company |
United States,
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 |
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