Catheter-related Bloodstream Infection Due to Central Venous Catheter
Conditions
Brief summary
Excelsior Medical has developed SwabCap™, a luer access valve disinfection cap. The SwabCap™ provides passive disinfection of valve top and threads without activating the luer access valve. This product promotes technique standardization and compliance in cleansing of the luer access valve prior to access. It acts as a physical barrier from touch and airborne contamination for up to 96 hours. This product has been endorsed and will be adopted for use at NorthShore University HealthSystem as a quality improvement initiative. This research study protocol is designed to confirm the anticipated benefit of this change in practice at NorthShore during the planned implementation and use. If the product performs as it has been designed to, the baseline rate of hub and subsequently intraluminal contamination will be diminished, thereby protecting patients with central lines from bloodstream infections due to contaminated hubs.
Interventions
DEVICEDisinfecting Cap
Replace standard practice with using the disinfecting cap
Sponsors
Endeavor Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients with peripherally inserted central catheters (PICC) inserted during their index hospitalization plus 5 or more consecutive PICC line days were consented and enrolled.
Exclusion criteria
* Minors and adult inpatients without PICCs or with PICCs for \< 5 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative contamination of intraluminal fluid from central venous catheters (discard) as measured in CFU/ml | Throughout the study with enrolled subjects (The catheter must have been in place for a period of 5 or more days before the first sample is taken.) | For the research project, we will monitor the colonization of access port colonization in routine as well as SwabCap™ cared for lines as follows: Specimen sampling will be done by obtaining one specimen of 1.0 mL of aspirate will be withdrawn from each unused catheter lumen during first morning rounds in a separate syringe; then placed in a epdiatric Isolator tube. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central line associated bloodstream infections | Throughout the study and from historical data | Central line-associated bloodstream infections (CLABSI) as defined by the National Healthcare Safety Network (NHSN) of all patients throughout 4 hospitals in 2009-2011. |
Countries
United States
Outcome results
None listed