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 — DEVICE
    The 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 used
    This 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 use
    This 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

Locations (1)

FacilityCityStateZIPSite coordinators
Park City HospitalPark CityUtah84060
Troy E. Madsen, MD
435-658-7500

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