Clinical trial NCT04048863: Effect of B. Braun Peripheral Advantage Program on Complications, Indwell Time and First Stick Success of PIVC Therapy
Official title: Assessment of the Effect of B. Braun Peripheral Advantage Program on Complications, Indwell Time and First Stick Success of PIVC Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Complications Associated With Device
Lead sponsor: B. Braun Medical Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-07
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The study will be divided into 4 Stages: 3 Clinical Stages and 1 Educational Stage.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Complications Associated With PIVC Use
timeFrame: Through study completion, an estimate of 1 year
Secondary outcomes:
measure: Catheter Indwell Time
timeFrame: Up to 48 hours and between 48 and 168 hours
measure: First Attempt Success Rates (First Stick Success)
timeFrame: Initial needle stick (baseline)
measure: Aggregate Costs Associated With Catheter Insertion
timeFrame: Through study completion, an estimate of 1 year
Other outcomes:
Locations:
city: La Crosse
country: United States
facility: Mayo Clinic
state: Wisconsin
Study officials:
affiliation: Mayo Clinic - La Crosse, WI
name: Camilla M Jaekel, RN
role: PRINCIPAL_INVESTIGATOR
References: