The PIV5Rights Safety and Quality Bundle

Sponsor

Hartford Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05869877

Collaborator

Vygon GmbH & Co. KG (Industry)

106

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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:

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

Condition or Disease	Intervention/Treatment	Phase
Catheter Complications	Device: Bundled	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

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 approachRandomized 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

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

The PIV5Rights Safety and Quality Bundle

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.
Cost Impact [1 year]
To compare cost with additional PIVC's inserted if PIVC failed to make it until the end of therapy
Outcome Analysis [1 year]
To compare IV related complications between the 2 groups (infiltrations, occlusions, phlebitis)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 years or older with not upper limit
admitted to the CB5 nursing unit
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hartford Hospital
Vygon GmbH & Co. KG

Investigators

Principal Investigator: Lee J Steere, ADN, Hartford Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lee Steere, Nurse Manager IV Therapy Services, Hartford Hospital

ClinicalTrials.gov Identifier:

NCT05869877

Other Study ID Numbers:

HHC-2022-0276

First Posted:

May 22, 2023

Last Update Posted:

May 22, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Study Results

No Results Posted as of May 22, 2023