BD Prevue II for Peripheral Intravenous Catheter Placement
Conditions
Brief summary
This post-market study is being conducted to generate safety and performance data on the BD Prevue(TM) II Peripheral Vascular Access System with Cue(TM) Needle Tracking Technology. The data will be utilized to support regional registrations (for example, EU MDR), and document any unforeseen residual risks.
Detailed description
This is an observational post-market, human subject study to evaluate the safety and performance of the BD Prevue(TM) II Peripheral Vascular Access System with Cue(TM) Needle Tracking Technology. Subjects will be recruited for participation based on need for IV catheter (midline catheters included) placement in a hospital setting. Enrolled subjects will go through ultrasound-guided peripheral intravenous catheter (USGPIV) placement as part of their clinical care. USGPIV is defined as a procedure in which an ultrasound machine is used to assist a qualified health care provider with IV cannulation from skin puncture through venipuncture via direct visualization on the ultrasound machine in real time.
Interventions
DEVICEBD Prevue(TM) II
Ultrasound-guided peripheral intravenous catheter placement procedure using the BD Prevue(TM) II
Sponsors
Becton, Dickinson and Company
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 1 years, or older * A patient who is a candidate for an ultrasound-guided peripheral intravenous catheter (midline catheters included) placement procedure using BD PrevueTM II Peripheral Vascular Access System with CueTM Needle Tracking Technology as assessed per their clinician(s) * Able and willing to provide informed consent or legal authorized representative (LAR) authorized to give consent on behalf of the subject
Exclusion criteria
* Any patient in whom ultrasound procedure might interfere with medical care or create undue hardship * Known, or suspected, allergy to materials contained in the BD PrevueTM II Peripheral Vascular Access System with CueTM Needle Tracking Technology or accessories that may come in contact with the patient * Localized skin, tissue, or other clinical factors that would prevent completion of the ultrasound procedure * Previous medical history that would prevent completion of the ultrasound procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Performance: To provide visualization of the target vessel in which to insert the chosen vascular access device | During the procedure | The PrevueTM II system is able to visualize the target vasculature (\>=70% with a 95% confidence interval) |
| Primary Performance: To have successful vascular access either by cannulation or blood return. | During the procedure | Successful access with the vascular access device, either by cannulation or blood return (\>=70% with a 95% confidence interval) |
| Primary Performance: To determine if BD Prevue(TM) II Peripheral Vascular Access System with Cue(TM) Needle Tracking Technology is able to provide visual needle tip location tracking to assist with insertion of the chosen vascular access device. | During the procedure | CueTM Needle Tracking System is able to properly display the location of the needle tip during vascular access device access insertion (\>=80% with a 95% confidence interval) |
| Primary Safety: To determine the incidence of device related adverse events, experienced by patient or user, when using the BD PrevueTM II Peripheral Vascular Access System with CueTM Needle Tracking Technology | During the procedure and 15 minutes after the procedure | Rate of device related adverse events (\<2%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Performance: To have successful first-attempt vascular access either by cannulation or blood return when using the BD PowerGlide Pro midline catheter. | During the procedure | Successful first-attempt access with the PowerGlide Pro midline catheter, either by cannulation or blood return (\>=70% with a 95% confidence interval) |
Countries
United States
Outcome results
None listed