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

• B. Braun Peripheral Advantage (PA) Program (Device): B. Braun PA includes: Christie VeinViewer® Vision2 , Introcan Safety® IV Catheters, STEADYCare™ Smallbore Extension Set, and the PA Education
• Hospital Standard of Care (Device): Standard of Care for PIVC access per hospital protocol

Primary outcomes

• 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 outcomes

• 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.
• 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.
• 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.

Sex: All, ages: 18 Years to any

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:

1. Male or female aged ≥18 years;
2. 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);
3. Have a medical condition that requires a PIVC anticipated to last for at least 48 hours;
4. Have intact skin at the site of insertion;
5. 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:

1. Are currently participating in another medical device or pharmaceutical study;
2. In the opinion of the Investigator, would not be suitable candidates for this study;
3. 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;
4. 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;
5. Patient has an existing non study related IV;
6. Was removed from any Stage of the study due to an AE associated with the PIVC.

Participant flow

Outcome results

• Complications Associated With PIVC Use (Primary), Count of units, Stick Attempts: Stage 1 Baseline 22; Stage 2 Education ; Stage 3 Run-In ; Stage 4 Post-Education
• Catheter Indwell Time (Secondary), Median, Hours: Stage 1 Baseline 25.00 (2.37 to 47.68); Stage 2 Education ; Stage 3 Run-In ; Stage 4 Post-Education
• First Attempt Success Rates (First Stick Success) (Secondary), Count of units, Stick Attempts: Stage 1 Baseline 28; Stage 2 Education ; Stage 3 Run-In ; Stage 4 Post-Education
• Aggregate Costs Associated With Catheter Insertion (Secondary)

Adverse events

Time frame: Each subject/patient was assessed from baseline (initial needle stick) up to 168 hours (longest catheter indwell time reported).

Other adverse events by term

Limitations and caveats: Due to limitations in the data collected only in Stage 1, no conclusions can be drawn on the impact of B. Braun PA Program on the incidence of complications associated with PIVC use.

• Study Protocol (PDF, 2021-02-03)
• Statistical Analysis Plan (PDF, 2021-12-03)

• Camilla M Jaekel, RN, Principal investigator, Mayo Clinic - La Crosse, WI