The PIV5Rights Safety and Quality Bundle

Not Applicable

Not yet recruiting

• Conditions: Catheter Complications
• Interventions: Device: Bundled

• Registration Number: NCT05869877
• Lead Sponsor: Hartford Hospital

Brief Summary

Purpose of this study is to see if a Peripheral Intravenous Catheter PIVC will last longer if inserted by a Registered Nurse (RN) who specializes in inserting PIVCs. Main question it aims to answer:

1. We believe that the use of the ultrasound, an RN who specializes in PIVC placement with the use of ultrasound and the use of best of class medical technology, may improve first stick success with PIVC insertion and the length of time the PIVC stays in place without showing any related complications

Detailed Description

After being informed about the study and potential risks, all patients giving written informed consent, patients will be randomized using Research Randomizer. At that time, the IV Therapist will insert a PIVC using standard of care medical equipment (control) or use ultrasound guidance, if needed, to insert a PIVC using the bundle with the best of class medical devices. Daily, a research RN will round, assess the site and take a picture. When therapy is complete or the PIVC malfunctions, the research RN will document the reason why the PIVC failed and that patient will no longer remain in the study.

Study Timeline

• Study First Submitted: 2023-05-09
• Study First Submitted QC: 2023-05-12
• Study First Posted: 2023-05-22
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Study Start: 2024-03-25
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• 18 years or older with not upper limit
• requires an IV for fluid and or medication administration
• able to read and write English and willing to complete written, informed consent

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Exclusion Criteria

• Unable to speak and read English
• Vulnerable populations such as minors (under age of 18)
• Incompetent or mentally challenged
• Prisoners
• Pregnant women or the unborn
• presented in the hospital prior to study start date

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Bundled	Bundled	Proficient RN who works in IV Therapy Department - 6 cm catheter inserted with or without ultrasound; chlorhexidine embedded transparent bordered dressing; transpore tape; microbore extension set with antireflux needleless connector

Primary Outcome Measures

Name	Time	Method
1 PIVC Per Patient Stay	1 year	To compare the proportion of patients for whom the initial catheter insertion is sufficient for their duration of care across the two groups

Secondary Outcome Measures

Name	Time	Method
Dwell Time	1 year	To compare dwell times between the 2 groups. Dwell time is defined as the time from line insertion to line removal.
Outcome Analysis	1 year	To compare IV related complications between the 2 groups (infiltrations, occlusions, phlebitis)
Cost Impact	1 year	To compare cost with additional PIVC's inserted if PIVC failed to make it until the end of therapy