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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-24

Study Completion Date

2021-07-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Complications Associated With Device

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

The study will be divided into 4 Stages: 3 Clinical Stages and 1 Educational Stage.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Stage 1 Baseline

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

Group Type ACTIVE_COMPARATOR

Hospital Standard of Care

Intervention Type DEVICE

Standard of Care for PIVC access per hospital protocol

Stage 2 Education

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

Group Type OTHER

B. Braun Peripheral Advantage (PA) Program

Intervention Type DEVICE

B. Braun PA includes: Christie VeinViewer® Vision2 , Introcan Safety® IV Catheters, STEADYCare™ Smallbore Extension Set, and the PA Education

Stage 3 Run-In

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

Group Type OTHER

B. Braun Peripheral Advantage (PA) Program

Intervention Type DEVICE

B. Braun PA includes: Christie VeinViewer® Vision2 , Introcan Safety® IV Catheters, STEADYCare™ Smallbore Extension Set, and the PA Education

Stage 4 Post-Education

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

Group Type OTHER

B. Braun Peripheral Advantage (PA) Program

Intervention Type DEVICE

B. Braun PA includes: Christie VeinViewer® Vision2 , Introcan Safety® IV Catheters, STEADYCare™ Smallbore Extension Set, and the PA Education

Interventions

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B. Braun Peripheral Advantage (PA) Program

B. Braun PA includes: Christie VeinViewer® Vision2 , Introcan Safety® IV Catheters, STEADYCare™ Smallbore Extension Set, and the PA Education

Intervention Type DEVICE

Hospital Standard of Care

Standard of Care for PIVC access per hospital protocol

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No