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

NCT04048863 | Terminated Results FDA Device

• 1 other identifier: US-N-H-1801
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Complications Associated With Device

Outcome Measures

Primary Outcomes (1)

• Complications Associated With PIVC Use

  \[Planned\] 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.

  Through study completion, an estimate of 1 year

Secondary Outcomes (3)

• Catheter Indwell Time

  Up to 48 hours and between 48 and 168 hours

• First Attempt Success Rates (First Stick Success)

  Initial needle stick (baseline)

• Aggregate Costs Associated With Catheter Insertion

  Through study completion, an estimate of 1 year

Study Arms (4)

Stage 1 Baseline

ACTIVE COMPARATOR

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

Device: Hospital Standard of Care

Stage 2 Education

OTHER

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

Device: B. Braun Peripheral Advantage (PA) Program

Stage 3 Run-In

OTHER

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

Device: B. Braun Peripheral Advantage (PA) Program

Stage 4 Post-Education

OTHER

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

Device: B. Braun Peripheral Advantage (PA) Program

Interventions

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

Stage 2 Education; Stage 3 Run-In; Stage 4 Post-Education

Hospital Standard of Care DEVICE

Standard of Care for PIVC access per hospital protocol

Stage 1 Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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:

• 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.

Sponsors & Collaborators

• B. Braun Medical Inc.: lead

Study Sites (1)

Mayo Clinic

La Crosse, Wisconsin, 54601, United States

Location

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.

Results Point of Contact

• Title: Dr. Diana Valencia
• Organization: B. Braun Medical Inc.

diana.valencia@bbraunusa.com

610-596-2875

Study Officials

• Camilla M Jaekel, RN

  Mayo Clinic - La Crosse, WI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 7, 2019
• Study Start: January 24, 2020
• Primary Completion: July 27, 2021
• Study Completion: July 27, 2021
• Last Updated: August 1, 2022
• Results First Posted: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)