The PIV5Rights Safety and Quality Bundle

NCT05869877 | Not Yet Recruiting FDA Device

• 1 other identifier: HHC-2022-0276
• Study Type: interventional
• Target: 106
• Locations: 0 countries
• Sites: N/A

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

Conditions

Catheter Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Dwell Time

  1 year

• Cost Impact

  1 year

• Outcome Analysis

  1 year

Study Arms (2)

Control

NO INTERVENTION

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

Bundled

EXPERIMENTAL

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

Interventions

Bundled DEVICE

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

Bundled

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hartford Hospital: lead
• Vygon GmbH & Co. KG: collaborator

Study Officials

• Lee J Steere, ADN

  Hartford Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lee J Steere, ADN

CONTACT

860-614-8254; Lee.Steere@hhchealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Manager IV Therapy Services

Model Details: Randomized controlled trial evaluating a peripheral intravenous catheter (PIVC) inserting using a bundled approach. Will evaluate the for extended dwell time and less complications compared to a PIVC using a non-bundled approach

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 22, 2023
• Study Start: March 25, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02