CRBSI - Catheter Related Bloodstream Infection
Conditions
Brief summary
This study is an investigational study to evaluate the safety and performance of the BD PosiFlush™ SafeScrub on needleless access devices.
Detailed description
This study is being conducted to generate clinical data to support the performance and safety of BD PosiFlush™ SafeScrub. The study data will be used for regulatory submission in EU.
Interventions
DEVICEBD PosiFlush™ SafeScrub
Clinicians will be advised to use BD PosiFlush™ SafeScrub as per the Instructions for Use for the treatment arm of the study. An independent nurse observer will observe and document any adverse events (e.g. local skin reaction, or irritation, or allergic response, up to and including symptoms of anaphylaxis), compliance with needleless access device scrubbing before flushing, device success rate (encapsulation and removal) as well as the time requirements and number of steps for needleless access device scrubbing prior to catheter flushes during medication administration process.
DEVICEBD PosiFlush™
Clinicians will be advised to follow and document the respective unit protocol, while using the standard pre-filled syringe (BD PosiFlush™ SP Syringe) and alcohol pad for scrubbing and flushing of NADs in the control arm of the study as the routine practice. An independent nurse observer will observe and document any adverse events (e.g. local skin reaction, or irritation, or allergic response, up to and including symptoms of anaphylaxis), compliance with needleless access device scrubbing before flushing, device success rate (encapsulation and removal) as well as the time requirements and number of steps for needleless access device scrubbing prior to catheter flushes during medication administration process.
Sponsors
Becton, Dickinson and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
At each participating site, one medical or surgical unit will conduct the treatment arm and one unit will conduct the control arm randomizing which unit will perform the treatment or control arm at the study site.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Any patient (≥18 years of age) in a high acuity hospital medical or surgical unit regardless of gender, with an eligible in-situ vascular access device and with a needleless access device (NAD). This includes patients who have a current VAD, whether it is newly placed or long-term access as part of their routine medical care. Eligible in-situ vascular access devices are peripheral intravenous catheters (PIVCs), peripherally inserted central catheters (PICCs), central venous catheters (CVCs) and implanted venous access ports. Eligible NADs are stopcocks, Y-sites, and needle-free connectors. 2. Expected to be available until 2 accesses are completed and for any periodic observation upto 15 min after each access. 3. Able and willing to provide informed consent or legal authorized representative (LAR) authorized to give consent on behalf of the participant.
Exclusion criteria
Any patient in whom observation might interfere with medical care or create undue hardship as determined by the patients care team. * Patients under the age of 18. * Patients suffering hypernatremia and fluid retention, when the administration of sodium or chloride could be clinically detrimental as determined by the study investigator. * Patients with a known allergy to any of the followings as determined by the study investigator: * Any of the components or materials of BD PosiFlush™ SafeScrub device or BD PosiFlush™ SP Syringe, or * 0.9% sodium chloride solution * Pregnant or breastfeeding women * Urine pregnancy test will be required for all women of childbearing age who want to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device related adverse events | 15 minutes | To assess the incidence of BD PosiFlush™ SafeScrub device-related adverse events up to 15 min after each access |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compliance rate of device scrubbing | 15 minutes | To assess if the compliance rate of needleless access device scrubbing before flushing with use of BD PosiFlush™ SafeScrub is higher compared to standard practice (i.e., use of pre-filled syringe (BD PosiFlush™ SP Syringe) and an alcohol pad) up to 15 min after each access |
| Device success rate | 15 minutes | To assess the performance of the BD PosiFlush™ SafeScrub. Percent success rate (≥85%) for BD PosiFlush™ SafeScrub to encapsulate the needleless access device, and to be removed from the needleless access device up to 15 min after each access |
Countries
Austria
Contacts
STUDY_CHAIRChristophe Van Laethem
Becton, Dickinson and Company BD Medication Delivery Systems/Catheter Care
Outcome results
None listed