The PIV5Rights Safety and Quality Bundle

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

Study Overview

• Status: Not yet recruiting
• Conditions: Catheter Complications
• Intervention / Treatment: Device: Bundled

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 Type: Interventional
• Enrollment (Estimated): 106
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lee J Steere, ADN; Phone Number: 860-614-8254; Email: Lee.Steere@hhchealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Proficient RN who works in IV Therapy Department - PIVC inserted without using ultrasound; non-bordered transparent dressing; 1-1.25 inch catheter; microbore extension set with neutral needleless connector; transpore tape. Standard of care
Experimental: 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	Device: Bundled; An peripheral intravenous catheter will be inserted by an RN specially trained in PIVC placement, with or without ultrasound. Using best of class medical products, will evaluate dwell time and complications of the PIVC inserted using a bundled approach versus one inserted with the bundle

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hartford Hospital
• Collaborators: Vygon GmbH & Co. KG
• Investigators: Principal Investigator: Lee J Steere, ADN, Hartford Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 25, 2024
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: May 12, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: HHC-2022-0276

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes