Complications Associated With Device Clinical Trial
Official title:
Assessment of the Effect of B. Braun Peripheral Advantage Program on Complications, Indwell Time and First Stick Success of PIVC Therapy
| Verified date | July 2022 |
| Source | B. Braun Medical Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 44 |
| Est. completion date | July 27, 2021 |
| Est. primary completion date | July 27, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Mayo Clinic | La Crosse | Wisconsin |
| Lead Sponsor | Collaborator |
|---|---|
| B. Braun Medical Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Catheter Indwell Time | Evaluate the effect of B. Braun PA on catheter indwell time associated with catheter insertion. | Up to 48 hours and between 48 and 168 hours | |
| Secondary | 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. | Initial needle stick (baseline) | |
| Secondary | Aggregate Costs Associated With Catheter Insertion | Evaluate the effect of B. Braun PA on aggregate costs associated with catheter insertion. | Through study completion, an estimate of 1 year |