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The PIV5Rights Safety and Quality Bundle

The PIV5Rights Safety and Quality Bundle

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05869877
Enrollment
106
Registered
2023-05-22
Start date
2024-03-25
Completion date
2024-05-01
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter Complications

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.

Interventions

DEVICEBundled

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

Sponsors

Vygon GmbH & Co. KG
CollaboratorINDUSTRY
Hartford Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
NONE

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 approach

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
1 PIVC Per Patient Stay1 yearTo compare the proportion of patients for whom the initial catheter insertion is sufficient for their duration of care across the two groups

Secondary

MeasureTime frameDescription
Dwell Time1 yearTo compare dwell times between the 2 groups. Dwell time is defined as the time from line insertion to line removal.
Cost Impact1 yearTo compare cost with additional PIVC's inserted if PIVC failed to make it until the end of therapy
Outcome Analysis1 yearTo compare IV related complications between the 2 groups (infiltrations, occlusions, phlebitis)

Contacts

Primary ContactLee J Steere, ADN
Lee.Steere@hhchealth.org860-614-8254

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026