Effect of B. Braun Peripheral Advantage Program on Complications, Indwell Time and First Stick Success of PIVC Therapy

Not Applicable

Terminated

Interventions: Device: B. Braun Peripheral Advantage (PA) Program
Device: Hospital Standard of Care

Brief Summary: Single sequence clinical study designed to evaluate the effectiveness of B. Braun PA on improved clinical outcomes, indwell time and first stick success of PIVC using B. Braun Peripheral Advantage (PA) by Registered Nurses (RNs).

The study will be conducted in the Emergency Department (ED) and/or Medical Surgical (MS) floor(s)/unit(s) in multiple hospitals.

Recruitment & Eligibility

Inclusion Criteria

RNs must complete all of the required B. Braun trainings in Stage 2 in order to participate in Stages 3 and 4.

Subjects must meet all of the following Inclusion Criteria:

Male or female aged ≥18 years;
The subject or the subject's LAR voluntarily agrees that the subject will participate in this study and is able to understand and sign the Informed Consent Form (ICF);
Have a medical condition that requires a PIVC anticipated to last for at least 48 hours;
Have intact skin at the site of insertion;
If the patient has an existing IV in one arm he/she must have a viable contralateral arm for additional PIVC insertion.

Exclusion Criteria

Subjects must not meet any of the following Exclusion Criteria:

Are currently participating in another medical device or pharmaceutical study;
In the opinion of the Investigator, would not be suitable candidates for this study;
The subject or his/her LAR is an employee of the Investigator or study center, or the sponsor, or have direct involvement in the study or other studies under the direction of that Investigator or study center, or are a family member of the employees or the Investigator;
Have a laboratory confirmed bloodstream infection within 48 hours prior to participation in the study. The assessment is based on clinical observations and not routine for all subjects;
Patient has an existing non study related IV;
Was removed from any Stage of the study due to an AE associated with the PIVC.

Arm && Interventions

Group	Intervention	Description
Stage 3 Run-In	B. Braun Peripheral Advantage (PA) Program	Familiarization of study RNs with the B. Braun devices and procedures in a clinical setting.
Stage 1 Baseline	Hospital Standard of Care	Study site to use standard of care PIVC device(s) and procedure(s) on patients.
Stage 2 Education	B. Braun Peripheral Advantage (PA) Program	RN education and training in the use of B. Braun PIVC products, devices and procedures.
Stage 4 Post-Education	B. Braun Peripheral Advantage (PA) Program	Study site uses B. Braun PIVC device(s) and procedure(s) on patients.

Primary Outcome Measures

Name	Time	Method
Complications Associated With PIVC Use	Through study completion, an estimate of 1 year	\[Planned\] Outcome: Evaluate the impact of B. Braun Peripheral Advantage (PA) Program on the number of stick attempts with complications associated with PIVC use. Due to the early termination in Stage 1, no data were collected from Stages 2 through 4 to perform comparative analyses.

Secondary Outcome Measures

Name	Time	Method
First Attempt Success Rates (First Stick Success)	Initial needle stick (baseline)	Evaluate the effect of B. Braun PA on first attempt success rates (first stick success) associated with catheter insertion.
Catheter Indwell Time	Up to 48 hours and between 48 and 168 hours	Evaluate the effect of B. Braun PA on catheter indwell time associated with catheter insertion.
Aggregate Costs Associated With Catheter Insertion	Through study completion, an estimate of 1 year	Evaluate the effect of B. Braun PA on aggregate costs associated with catheter insertion.