Observational Study of Central Venous Catheter (CVC) Occlusions and Central Line-Associated Blood Stream Infections (CLABSI) Using the

Clave™ Negative Displacement Connector Parul A. Patel, Susan Boehm, Ying Zhou, Catherine Zhu, Kari Peterson, Althea Grayes, Lance R. Peterson

NorthShore University HealthSystem, Evanston, IL.

Parul A. Patel MT(ASCP),CCRP

Dept. of Infectious Disease Research

2650 Ridge Avenue

Evanston, IL 60201

ppatel@northshore.org

Our data demonstrates that lines placed with standardized methods using a negative displacement connector and a disinfection cap can achieve very low rates of complications.

CLABSI and lumen occlusion can be prevented by using proper connectors, insertion techniques and management of the central line.

Assessment of new devices should approach clinical trials with the concept that very low rates of complications are achievable using contemporary devices and practices.

Table 1: Infection and clot rate by hospital

Total

patients Total lines

Total line-

days

Lines with Event per 100 lines Event per

1000 line days

Infection Clot Infection Clot Infection Clot

Hospital 1 921 1056 14925 8 231 0.76* 21.88† 0.54* 15.48†

Hospital 2 552 596 8286 4 69 0.67 11.58 0.48 8.33

Hospital 3 397 428 5030 3 38 0.70 8.88 0.60 7.56

Hospital 4 394 432 5427 6 40 1.39 9.26 1.11 7.37

*p>0.05 for all pair-wise comparison among 4 hospitals †p<.0001 for comparisons of hospital 1 vs. hospital 2, hospital 1 vs.. hospital 3 and hospital 1 vs.. hospital 4 On multivariate analysis, we were unable to determine a reason for differences in clot rates between the hospitals

Needle free connectors for central line access were introduced many years ago to prevent needlestick injuries among healthcare workers. While this goal was successfully achieved, there has been an increasing concern regarding complications such as Central Line-Associated Bloodstream Infection (CLABSI) and Central Venous Catheter (CVC) occlusion. These infections greatly increase the cost of the hospital stay as well as the length of stay for a patient. We performed a year long observational study where we used the CLAVE® Needle Free Connector manufactured by (ICU Medical), in a setting where disinfection caps containing 70% isopropyl alcohol cover all unused connectors and ports.

Figure 1. Central Line Procedural Checklist

Purpose: To document procedural practices in most settings where central lines are placed and maintained and identify deviations from this checklist.

Observer: _________________________________________Observation #_________

Observation Date: _____ / _____ / ________

Patient Name/MRN: _______________________________________________

Hospital/Unit/ Room Number:________________________________________

Department Performing Procedure:_____________________________________

Type of catheter

Tunneled: ___________________

Non-tunneled:_________________

Location of catheter

Subclavian □ R □ L

Brachiocephalic □ R □ L

Jugular: □ R □ L

Antecubital □ R □ L

Femoral: □ R □ L

Umbilical: □ R □ L

Basilic □ R □ L

Was a second practitioner in the room during insertion? □ Yes □ No □ N/A

Insertion Observation

Yes No Comments

1. Before the procedure, did the operator:

a. Cleansed hands immediately prior to procedure a. □ □

b. Sterilize procedure site (chlorhexidine) using correct b. □ □

motion and timing requirements (30 seconds)

c. Drape entire patient in a sterile fashion c. □ □

2. During the procedure, did the house staff assisting with the procedure:

d. Wear sterile gloves, hat, mask, and sterile gown (all must be worn) d. □ □

e. Sterile field maintained e. □ □

f. Catheter cart/kit used f. □ □

g. All personnel assisting follow the above precautions g. □ □

3. After the procedure (exception is ISCU lines):

h. Sterile technique maintained when applying dressing? h. □ □

i. Biopatch and securement device placed appropriately i. □ □

j. Dressing labeled for date and initials j. □ □

k. Clave and Swab Cap placed on hubs k. □ □

A total of 2,264 patients were enrolled for this study.

There were 21 CLABSI with a rate of 0.84% of lines and 0.62 per 1,000 line days.

A total of 378 clots occurred with a rate of 15.05% of lines and 11.23 per 1,000 line days. Infection and clot rate by hospital are in Table 1.

We performed a total of 85 observations of catheter insertions between all 4 hospitals.

Each observation had a list of 11 criteria that needed to be followed for central line placement.

One of the criteria in the central line insertion checklist indicates "Assisting personnel need to follow gown/glove/mask precautions". There was only 1 member of the VAT placing the central lines thereby rendering this response as not applicable because there were no assistant personnel assisting with the procedure.

Thus, there were 925 individual criteria measurements that needed to be followed.

We observed that 881 criteria were followed which gives us a 95% protocol adherence rate for the insertion policy criteria.