The PIV5Rights Safety and Quality Bundle

Catheter Complications Clinical Trial

Official title:

The PIV5Rights Safety and Quality Bundle

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05869877
• Other study ID #: HHC-2022-0276
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 25, 2024
• Est. completion date: May 1, 2024

Study information

• Verified date: February 2024
• Source: Hartford Hospital
• Contact: Lee J Steere, ADN
• Phone: 860-614-8254
• Email: Lee.Steere[@]hhchealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 106
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Catheter Complications

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hartford Hospital	Vygon GmbH & Co. KG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Cost Impact	To compare cost with additional PIVC's inserted if PIVC failed to make it until the end of therapy	1 year
Secondary	Outcome Analysis	To compare IV related complications between the 2 groups (infiltrations, occlusions, phlebitis)	1 year