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

Stopped early · Not applicable

Conditions studied: Complications Associated With Device

In brief

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.

Key facts

Study ID

NCT04048863

Run by

B. Braun Medical Inc.

People needed

44

Starts

2020-01-24

Expected to finish

2021-07-27

Last updated by the study team

2022-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic — La Crosse, Wisconsin, United States

Full record on ClinicalTrials.gov

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