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

B. Braun

Status: Terminated

Conditions: Complications Associated With Device

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04048863

US-N-H-1801

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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44 participants in 4 patient groups

Stage 1 Baseline

Active Comparator group

Description:

Study site to use standard of care PIVC device(s) and procedure(s) on patients.

Treatment:

Device: Hospital Standard of Care

Stage 2 Education

Other group

Description:

RN education and training in the use of B. Braun PIVC products, devices and procedures.

Treatment:

Device: B. Braun Peripheral Advantage (PA) Program

Stage 3 Run-In

Other group

Description:

Familiarization of study RNs with the B. Braun devices and procedures in a clinical setting.

Treatment:

Device: B. Braun Peripheral Advantage (PA) Program

Stage 4 Post-Education

Other group

Description:

Study site uses B. Braun PIVC device(s) and procedure(s) on patients.

Treatment:

Device: B. Braun Peripheral Advantage (PA) Program