The PIV5Rights Safety and Quality Bundle

NCT ID: NCT05869877

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-25
• Study Completion Date: 2024-05-01

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.

Conditions

Catheter Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Bundled

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vygon GmbH & Co. KG

INDUSTRY

Sponsor Role: collaborator

Hartford Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lee Steere

Nurse Manager IV Therapy Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lee J Steere, ADN

Role: PRINCIPAL_INVESTIGATOR

Hartford Hospital

Central Contacts

Lee J Steere, ADN

Role: CONTACT

Lee.Steere@hhchealth.org

860-614-8254

Other Identifiers

HHC-2022-0276

Identifier Type: -

Identifier Source: org_study_id