PIVO Use for Blood Cultures in the Emergency Department

NCT07348289 | Recruiting FDA Device

• 2 other identifiers: 1053426PIVO-ED
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sepsis; Device Performance; Emergency Medicine

Outcome Measures

Primary Outcomes (2)

• PIVO utilization

  The investigators will assess utilization of the device for blood cultures obtained in the emergency department through review of the medical record and documentation of cases in which PIVO was used for blood cultures as a proportion of all blood cultures obtained.

  From baseline until 12 months after baseline

• Contamination rates

  The investigators will assess contamination rates for blood cultures obtained using the device compared to blood cultures obtained without the device.

  From baseline until 12 months after baseline

Secondary Outcomes (1)

• Staff satisfaction and willingness to recommend the device

  Six months after study initiation

Study Arms (2)

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.

Device: PIVO device, a needle-free blood draw device

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.

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."

Patients in whom PIVO is used

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study evaluates patients in whom blood cultures are obtained in the emergency department during the study period. The primary population of interest is those in whom the PIVO device is used, with comparison to the overall population of patients in whom blood cultures are obtained.

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (1)

Park City Hospital

Park City, Utah, 84060, United States

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Troy E. Madsen, MD

CONTACT

435-658-7500; troy.madsen@imail.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 16, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)