Recruiting

PIVO Device

Sponsor:

Intermountain Health Care, Inc.

Code:

NCT07348289

Conditions

Sepsis

Device Performance

Emergency Medicine

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

PIVO device, a needle-free blood draw device

Study Details

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

Study ID

NCT07348289

Start date

Oct 1, 2025

Status verified date

Dec, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria: Patients in whom blood cultures are obtained in the emergency department.

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Exclusion Criteria: none

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Study Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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

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."

Primary outcome measure

  • PIVO utilization [ Time Frame: From baseline until 12 months after baseline ]
  • Contamination rates [ Time Frame: From baseline until 12 months after baseline ]

Central Contacts and Locations

Central contacts

Troy E. Madsen, MD

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

Locations

Park City Hospital

Recruiting

Park City, Utah, United States, 84060

Contacts

Troy E. Madsen, MD

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

More Information

Sponsor

Intermountain Health Care, Inc.

Last update posted

Jan 16, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Intermountain Health Care, Inc. on 2026-01-16.