PIVO Use for Blood Cultures in the Emergency Department
Part of paid clinical trials in Park City, Utah.
- Sponsor
- Intermountain Health Care, Inc.
- Study ID
- NCT07348289
- Status
- Recruiting
Conditions
- Device Performance
- Emergency Medicine
- Sepsis
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- PIVO device, a needle-free blood draw device — DEVICEThe PIVO device, a needle-free blood draw device, may be used through an IV to obtain a blood sample and extends beyond the IV to ideally reduce the potential for contamination and to improve success in obtaining a sample. Per Google AI: "PIVO™ by Velano Vascular stands for Peripheral IV Origin, a needle-free blood draw device that uses a patient's existing peripheral IV (PIV) line to collect blood, avoiding extra needle sticks and reducing pain, hemolysis, and contamination, facilitating the "One-Stick Hospital Stay" goal for better patient care."
Study Details
The investigators will implement a protocol for use of the PIVO device for blood culture collection in the emergency department. This protocol utilizes the device in various scenarios to reduce needlesticks while allowing for accurate and appropriate assessment of potential pathogens in the bloodstream. The study team will train staff on use of the device then monitor utilization and contamination rates among emergency department patients.
Key Dates
- Start date
- Oct 1, 2025
- Status verified
- Dec 2025
- Primary completion
- Oct 31, 2026
- Completion
- Jul 31, 2027
Study Design
- Enrollment
- 10,000 participants (estimated)
Arms
- Arm: Patients in whom PIVO is usedThis cohort includes patients in whom PIVO is used to assess successful use of the device and contamination rates among blood cultures obtained.
- Arm: Blood cultures obtained without PIVO useThis comparison group includes patients in whom the PIVO device is not used for comparison to blood cultures in which it is used.
Primary Outcome Measure
PIVO utilization [ Time Frame: From baseline until 12 months after baseline ]
Central Contacts
- Troy E. Madsen, MD435-658-7500
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Park City Hospital | Park City | Utah | 84060 |
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