Complications Associated With DeviceNCT04048863

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

A study testing B. Braun Peripheral Advantage (PA) Program in people with Complications Associated With Device, run by B. Braun Medical Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Complications Associated With Device
What is being tested?: B. Braun Peripheral Advantage (PA) Program
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteUnited States
Study dates: 24 Jan 2020to 27 Jul 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic
La Crosse, Wisconsin, 54601

Other trials in United States

About this study

Official title: Assessment of the Effect of B. Braun Peripheral Advantage Program on Complications, Indwell Time and First Stick Success of PIVC Therapy

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
Being tested: B. Braun Peripheral Advantage (PA) Program, Hospital Standard of Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04048863
Study group	Role	What they receive
Stage 1 Baseline	Active comparator	Study site to use standard of care PIVC device(s) and procedure(s) on patients. Receives: Device: Hospital Standard of Care
Stage 2 Education	Other	RN education and training in the use of B. Braun PIVC products, devices and procedures. Receives: 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. Receives: 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. Receives: Device: B. Braun Peripheral Advantage (PA) Program

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Through study completion, an estimate of 1 year

Secondary outcomes (3)

Catheter Indwell Time
Evaluate the effect of B. Braun PA on catheter indwell time associated with catheter insertion.
Measured: Up to 48 hours and between 48 and 168 hours
First Attempt Success Rates (First Stick Success)
Evaluate the effect of B. Braun PA on first attempt success rates (first stick success) associated with catheter insertion.
Measured: Initial needle stick (baseline)
Aggregate Costs Associated With Catheter Insertion
Evaluate the effect of B. Braun PA on aggregate costs associated with catheter insertion.
Measured: Through study completion, an estimate of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jan 202027 Jul 2021

First posted7 Aug 2019
Study start24 Jan 2020
Primary completion27 Jul 2021
Study completion27 Jul 2021

Why it stopped: This study was terminated due to recruitment futility resulting from the significant impact of the COVID-19 pandemic to our intended study population and facility personnel.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Complications Associated With DeviceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Sequential
Model description: The study will be divided into 4 Stages: 3 Clinical Stages and 1 Educational Stage.
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04048863
Sponsor's protocol ID: US-N-H-1801
Status last verified: Jul 2022
First submitted: 6 Aug 2019
Last updated: 1 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Complications Associated With Device trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of the Effect of B. Braun Peripheral Advantage Program on Complications, Indwell Time and First Stick Success of PIVC Therapy
ClinicalTrials.gov ID: NCT04048863
Acronym / sponsor ID: US-N-H-1801
Conditions: Complications Associated With Device
Study type: Interventional
Recruitment status: TerminatedReason stopped: This study was terminated due to recruitment futility resulting from the significant impact of the COVID-19 pandemic to our intended study population and facility personnel.
Enrolment: 44 participants (actual)
Lead sponsor: B. Braun Medical Inc.Industry (pharma, biotech, devices)
Study start: 24 Jan 2020 (actual)
Primary completion: 27 Jul 2021 (actual)
Study completion: 27 Jul 2021 (actual)
First posted: 7 Aug 2019 (actual)
Results: Posted 29 Jul 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study will be conducted in the Emergency Department (ED) and/or Medical Surgical (MS) floor(s)/unit(s) in multiple hospitals.

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4
Model description: The study will be divided into 4 Stages: 3 Clinical Stages and 1 Educational Stage.

Arm	Type	Receives
Stage 1 Baseline	Active comparator	Device: Hospital Standard of CareStudy site to use standard of care PIVC device(s) and procedure(s) on patients.
Stage 2 Education	Other	Device: B. Braun Peripheral Advantage (PA) ProgramRN education and training in the use of B. Braun PIVC products, devices and procedures.
Stage 3 Run-In	Other	Device: B. Braun Peripheral Advantage (PA) ProgramFamiliarization of study RNs with the B. Braun devices and procedures in a clinical setting.
Stage 4 Post-Education	Other	Device: B. Braun Peripheral Advantage (PA) ProgramStudy site uses B. Braun PIVC device(s) and procedure(s) on patients.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
B. Braun Peripheral Advantage (PA) ProgramB. Braun PA includes: Christie VeinViewer® Vision2 , Introcan Safety® IV Catheters, STEADYCare™ Smallbore Extension Set, and the PA Education	Device	Stage 2 Education, Stage 3 Run-In, Stage 4 Post-Education
Hospital Standard of CareStandard of Care for PIVC access per hospital protocol	Device	Stage 1 Baseline

Primary outcome

Complications Associated With PIVC Use
Time frame: 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.

3 secondary outcomes

Catheter Indwell Time
Time frame: Up to 48 hours and between 48 and 168 hours
First Attempt Success Rates (First Stick Success)
Time frame: Initial needle stick (baseline)
Aggregate Costs Associated With Catheter Insertion
Time frame: Through study completion, an estimate of 1 year

Results and safety

Results posted to the registry on 29 Jul 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stage 1 Baseline	43	43
Stage 2 Education	0	0
Stage 3 Run-In	0	0
Stage 4 Post-Education	0	0

Primary outcome: Complications Associated With PIVC Use

Time frame: Through study completion, an estimate of 1 year. Count of units. Unit: Stick Attempts

Measure	Stage 1 Baseline n = 43	Stage 2 Education n = 0	Stage 3 Run-In n = 0	Stage 4 Post-Education n = 0
Value	22	–	–	–

Population analysed: Study stopped due to recruitment futility. Stages 2 through 4 were not conducted.

3 secondary outcomes are reported in the full results.

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 reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stage 1 Baseline	0 of 43 (0%)	12 of 43 (27.9%)	0 of 43
Stage 2 Education	0 of 0	0 of 0	0
Stage 3 Run-In	0 of 0	0 of 0	0
Stage 4 Post-Education	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Enrolling by invitationObservational study
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Postoperative Pain, Postoperative Edema
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Camilla M Jaekel, RN principal investigator

Mayo Clinic - La Crosse, WI

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing B. Braun Peripheral Advantage (PA) Program in people with Complications Associated With Device, run by B. Braun Medical Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complications Associated With PIVC Use (time frame: Through study completion, an estimate of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04048863.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.