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Central Venous Catheter Protective Connector Caps Reduce Intraluminal Catheter-Related Infection
O R I G I N A L
A R T I C L E
Central Venous Catheter Protective Connector Caps Reduce Intraluminal Catheter-Related Infection Chuck Ramirez, BA, RRT, VA-BC Antonina M. Lee, MEd, MPH, RN, CIC Ken Welch, MD Banner Estrella Medical Center, Phoenix, AZ
Abstract Background: Central line-associated blood stream infection (CLABSI) rates in adult care intensive care units have been decreasing across the board. However, we continued to see just a few infections in patients whose catheters are in for >4 days. Therefore, we looked at infections associated with intraluminal contamination to help reduce our infection rate. Methods: A protective cap trial was developed and implemented in 2 intensive care units. All of the central venous catheter and intravenous tubing access valves were covered with a protective cap saturated with alcohol. This intervention eliminated the need to wipe off intravenous access points with an alcohol swab. The study was done as a nonrandomized prospective trial occurring March 1, 2011 through February 29, 2012. Results: During 2010, there were 4 CLABSI-related infections. By the end of the trial, we had incurred 1 catheterassociated blood stream infection. CLABSI rate reduced from 1.9 in 2010 to 0.5 during the 1-year trial period. Conclusions: The implementation of the port protector cap system resulted in lower infection rates compared with an alcohol swab technique. Our results indicate that consistent use of the caps in tandem with strict compliance does influence CLABSI rates. Keywords: port protector, protective cap, intraluminal infections
Introduction or the past 3 years, our institution has been working on decreasing central line-associated blood stream infection (CLABSI) rates in our intensive care unit (ICU) and throughout the facility. Rates decreased considerably after all the elements of the insertion bundle were implemented, but occasional infections still occurred in patients requiring extended intravenous (IV) therapy, whose central lines could not be discontinued. These infections usually occurred between 5 and 10 days into the hospitalization and often required an extended stay in the ICU, delayed planned discharges, and increased patient morbidity. We proposed that some of these later-occurring infections were due to contamination occurring
F
Correspondence concerning this article should be addressed to [email protected] http://dx.doi.org/10.1016/j.java.2012.10.002 Copyright Ó 2012, ASSOCIATION FOR VASCULAR ACCESS. Published by Elsevier Inc. All rights reserved.
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when the line was being accessed, causing intraluminal contamination. The question then becomes: does decreasing the chances of contaminating the line during access have an influence on CLABSI rates? To that effect, a trial study was proposed using a disinfecting plastic protective connector with an alcohol-saturated sponge inside the cap. The cap remains on the needleless connector until the connection is needed, leaving the connector disinfected. Once access is completed, a new cap is placed over the connector. This provides a uniform approach to disinfecting any central vascular access device. A vast majority of current prevention bundles or strategies have primarily focused on extraluminal colonization. This was a good strategy for a majority of the central venous catheter (CVC) devices intended for a dwell time usually <72 hours, resulting in a rapid and substantial CLABSI rate decrease across the board.1 However, we continued to see infections in patients whose catheters were in place >72 hours. Therefore, we looked at infections associated with intraluminal contamination to help reduce our infection rate. Numerous risk factors for CLABSI associated with needleless connectors have been proposed. Some are attributed to
2012
poor hand washing before manipulation, inability to properly disinfect the connection site due to poor design, aseptic device management, and frequency of the connector exchange. Device design, product materials, engineering components, and features of the various connectors vary widely among the currently available products. Making decisions based on the connectors alone can be difficult for clinical staff.2 In addition, several studies looking at intraluminal contamination from the needleless connector have demonstrated that high levels of contamination can be seen colonizing the connector and subsequently moving into the CVC. Even with varying levels of disinfection, colonization can still occur. Further, the epidemiology of gram-negative versus grampositive organisms may require varying rates of disinfection.3 Considering that colonization can occur with disinfection, some consider disinfection unnecessary. Studies of current IV practices demonstrated that 56% of registered nurses typically do not believe it is necessary to disinfect catheter hubs. And >90% of nurses do not cover an intermittent IV infusion.4 Looking back at our central line infection cases, it became increasingly clear that we were potentially having maintenance- or intraluminal-related infections. Evidence of this is also in trials that show significantly high bacterial counts transferred through the valve.5 Therefore, we proceeded with an evaluation of the cap. We chose the Curos Port Protector (Ivera Medical, San Diego, CA) to evaluate. At the initiation of the trial, this was the only cap available that we were aware of. Subsequently, several other products have entered the marketplace. When developing our strategy, we discussed our current practice and the various options available to reduce intraluminal-related issues. Current practice for disinfecting needleless connectors is to clean the hub with an alcohol sponge for 15 seconds. Options were as simple as enhanced education around CVC management to chlorhexidine scrub. After much debate about which direction to pursue, we decided on the Curos cap with 70% isopropyl alcohol. Methods Banner Estrella Medical Center is a 214-bed community hospital offering cardiac surgery, general surgery, orthopedic surgery, and hematologyeoncology services. This facility inserts >1,500 central lines annually, including peripherally inserted central catheters, tunneled caths, and ports. Our study attempted to decrease intraluminal contamination by minimizing the introduction of contaminants through inadequately disinfected needleless connectors. To that end, 2 ICUs had all the CVC and IV tubing needleless connectors covered with a protective cap. This study was done as a nonrandomized prospective trial occurring March 1, 2011 through February 29, 2012. We defined CLABSI according to the Centers for Disease Control and Prevention’s National Healthcare Safety Network guidelines.6 The study was preapproved by hospital administration and critical care committee. The study sample was all the patients in our ICU with an indwelling central line who were receiving IV treatments through the line. The decision to include all patients was made
because the facility had reliable data on CLABSI-related infections for the previous 3 years and because introducing the cap was the only change made to the process of inserting and caring for the lines. No randomization was attempted, the premise being that during the study period the patient mix would be comparable with the patient mix seen during the 3 previous years. The outcomes measure was the CLABSI rate. Statistical methods Unpaired t tests were used to compare the data from the 12 months before the trial start with the 12 months of the trial. The result from the comparison revealed a 2-tailed p value of 0.1260, a mean of 1.525, and a 95% confidence interval of -0.463 to 3.513. The mean of Group One minus Group Two was 1.5250.959 with t22¼1.5906. Although the p value is not considered significant by conventional criteria, we saw a 75% reduction in the number of CLABSIs in our ICU. Intervention Trial design and implementation developed through the critical care service line. Multidisciplinary meetings were conducted emphasizing education on trial design and implementation. Focused education was given to unit registered nurses and respiratory therapists regarding the need to use the cap on all connectors because these professionals share responsibility for CVC maintenance. The simplicity of the product involved in the trial did not necessitate extensive training or pre- and post-testing. Adding connectors or deadend devices to a CVC is a fairly well-established function and is part of the routine care of CVCs. The caps were made readily available in medication rooms. Par levels were maintained at specific levels throughout the trial so no lapses in compliance could occur. A survey tool was also implemented to document compliance with the cap. This tool was utilized throughout the trial during rounding. During each rounding event, the trained observers recorded how many of the connectors were covered by a cap. Observers were uniformly trained in using the form to ensure validity and reliability. Trial compliance or cap use was the biggest challenge; that is, maintaining consistent use of the cap on every access connector. Results During 2010, there were 4 CLABSI-related infections in our ICU. After the trial started (during the period from March 2011 to March 2012), there was 1 catheter-associated blood stream infection. The average monthly number of central line days in 2011 was 180 compared with 176 in 2010, with a high of 208 and a low of 153. The single infection occurred in a patient who experienced a cardiac arrest while in a diagnostic area and had a femoral line emergently inserted. The line could not be removed and was left in place for an extended period of time as the only vascular access for this patient. The CLABSI data were reported to the National Healthcare Safety Network, which resulted in a standardized infection rate change of 1.259 in 2010 to 0.308 in 2011. The CLABSI rate decreased
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Figure 1. Twenty-two-month incidence of CLABSI and yearly average rate. from 1.9/1,000 catheter days in 2010 down to 0.5/1,000 catheter days in 20117 (Figure 1). The tool developed to monitor compliance was utilized during every rounding event to document adherence to trial by measuring how many of the eligible access sites had a cap in place. Compliance varied from a low of 25% to a high of 100%. If a single IV administration set was being used, it was considered protected or 100% compliant if there was a cap on every needleless connector. If there were additional administration sets or piggybacks, they were included in the compliance rate (Figure 2). Some months into the study, we noted that cap compliance was low. The main barrier identified by users was related to
Figure 2. Percentage of monthly compliance with cap use.
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Figure 3. Compliance variance utilizing single cap vs multiple cap strips.
cap availability at the bedside. A decision was made to add cap strips that could be hung on IV poles in patient rooms. Formalized product education was done concurrently. The strips were added during Month 5 of the trial. The average compliance after adding the strips increased from 63% to 80%. The average compliance throughout the 12-month trial was 73%. Single caps remained an option throughout the trial (Figure 3). Discussion There are several studies available to help understand the various types of intraluminal contamination. Studies on cleaning surfaces with various solutions and durations, best connector, and valved catheters have been conducted. Ultimately, these are all attempts to reduce intraluminal catheter infection. The 70% isopropyl alcohol cap is also an attempt to reduce intraluminal contamination. However, the strategy is different in respect to the cap creating an environment that prevents colonization in the first place. Our 1-year trial resulted in a significant decrease in CLABSIs. A decrease of 1.4/1,000 catheter days from 2010 to 2011 was achieved. A point of interest is the 1 catheter infection identified during the trial was also during the same month with the lowest cap use. Although no direct relationship can be established, they did occur during the same month. Cap use throughout the trial required ongoing training and encouragement to change practice. During the initial 5 months, we used single caps. Utilization rates averaged about 63%. We observed issues with availability and convenience because the nurses and respiratory therapists did not always have the caps readily available. In July, we switched to a different cap package. The currently used caps are available on a strip of 10 that can be conveniently hung on an IV pole. Use increased to an average of 80%. The average overall use during the entire trial came in at 73%. A significant drop in CLABSI was still achieved despite not reaching a higher compliance rate. Over the course of 1 year, the hospital used 37,850 protective connector caps. There was some migration to an oncology
2012
unit where staff members also wanted to use the caps. The exact volume used in the oncology unit was very small in relation to the volume used in our ICU. Cost for the trial was approximately $10,000 (maybe a little less with the uncontrolled cap migration). The Centers for Disease Control and Prevention estimate the cost of CLABSIs is substantial, both in terms of morbidity and financial resources expended. Their estimate is that, on average, hospitals have an increase in patient length of stay by 2 to 5 days for every CLABSI. The attributable cost per CLABSI event is variable, but on average, the estimated cost reported in the literature is $16,350.8 Based on these recognized expense projections and CLABSI reduction, a calculated net savings of $39,050 was realized in this trial. This does not include the additional morbidities associated with CLABSI, including increased mortality, sepsis, thrombus/deep vein thrombosis, multiple catheterizations, and loss of useful vasculature. Conclusions The goal of our trial was to find out if maintaining sterility at the port site using an alcohol-impregnated cap would have an affect on intraluminal catheter-associated blood stream infections in our ICU. Our results indicate that consistent use of the caps in tandem with utilization compliance does influence CLABSI rates.
References 1. Cobb D, High K. A controlled trial of scheduled replacement of central venous and pulmonary-artery catheters. N Engl J Med. 1992;327:1062-1068. 2. Mathers D. Evidence-based practice: improving outcomes for patients with a central venous access device. J Assoc Vasc Access. 2011;16:64-72. 3. Simmons S, Bryson C, Porter S. “Scrub the hub”: cleaning duration and reduction in bacterial load on central venous catheters. Crit Care Nurs Q. 2011;34:31-35. 4. Hadaway L. Intermittent intravenous administration sets: survey of current practices. JAVA. 2011;12:143-147. 5. Ryder M, Fisher S, Hamilton G, et al. Bacterial transfer through needle free connectors: comparison of nine different devices. Poster presented at 2007 Meeting of The Society for Healthcare Epidemiology of America. 6. O’Grady NP, Alexander M, Dellinger EP, et al. Guidelines for the prevention of intravascular catheter-related infections. Centers for Disease Control and Prevention website. http:// www.cdc.gov/hicpac/pdf/guidelines/bsi-guidelines-2011.pdf. Accessed November 5, 2012. 7. National Healthcare Safety Network. Source of aggregate data: NHSN report. Am J Infect Control. 2009;37:783-805. 8. Mermel L. Prevention of intravascular catheter-related infections. Ann Intern Med. 2000;132:391-402.
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A R T I C L E
Central Venous Catheter Protective Connector Caps Reduce Intraluminal Catheter-Related Infection Chuck Ramirez, BA, RRT, VA-BC Antonina M. Lee, MEd, MPH, RN, CIC Ken Welch, MD Banner Estrella Medical Center, Phoenix, AZ
Abstract Background: Central line-associated blood stream infection (CLABSI) rates in adult care intensive care units have been decreasing across the board. However, we continued to see just a few infections in patients whose catheters are in for >4 days. Therefore, we looked at infections associated with intraluminal contamination to help reduce our infection rate. Methods: A protective cap trial was developed and implemented in 2 intensive care units. All of the central venous catheter and intravenous tubing access valves were covered with a protective cap saturated with alcohol. This intervention eliminated the need to wipe off intravenous access points with an alcohol swab. The study was done as a nonrandomized prospective trial occurring March 1, 2011 through February 29, 2012. Results: During 2010, there were 4 CLABSI-related infections. By the end of the trial, we had incurred 1 catheterassociated blood stream infection. CLABSI rate reduced from 1.9 in 2010 to 0.5 during the 1-year trial period. Conclusions: The implementation of the port protector cap system resulted in lower infection rates compared with an alcohol swab technique. Our results indicate that consistent use of the caps in tandem with strict compliance does influence CLABSI rates. Keywords: port protector, protective cap, intraluminal infections
Introduction or the past 3 years, our institution has been working on decreasing central line-associated blood stream infection (CLABSI) rates in our intensive care unit (ICU) and throughout the facility. Rates decreased considerably after all the elements of the insertion bundle were implemented, but occasional infections still occurred in patients requiring extended intravenous (IV) therapy, whose central lines could not be discontinued. These infections usually occurred between 5 and 10 days into the hospitalization and often required an extended stay in the ICU, delayed planned discharges, and increased patient morbidity. We proposed that some of these later-occurring infections were due to contamination occurring
F
Correspondence concerning this article should be addressed to [email protected] http://dx.doi.org/10.1016/j.java.2012.10.002 Copyright Ó 2012, ASSOCIATION FOR VASCULAR ACCESS. Published by Elsevier Inc. All rights reserved.
210
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when the line was being accessed, causing intraluminal contamination. The question then becomes: does decreasing the chances of contaminating the line during access have an influence on CLABSI rates? To that effect, a trial study was proposed using a disinfecting plastic protective connector with an alcohol-saturated sponge inside the cap. The cap remains on the needleless connector until the connection is needed, leaving the connector disinfected. Once access is completed, a new cap is placed over the connector. This provides a uniform approach to disinfecting any central vascular access device. A vast majority of current prevention bundles or strategies have primarily focused on extraluminal colonization. This was a good strategy for a majority of the central venous catheter (CVC) devices intended for a dwell time usually <72 hours, resulting in a rapid and substantial CLABSI rate decrease across the board.1 However, we continued to see infections in patients whose catheters were in place >72 hours. Therefore, we looked at infections associated with intraluminal contamination to help reduce our infection rate. Numerous risk factors for CLABSI associated with needleless connectors have been proposed. Some are attributed to
2012
poor hand washing before manipulation, inability to properly disinfect the connection site due to poor design, aseptic device management, and frequency of the connector exchange. Device design, product materials, engineering components, and features of the various connectors vary widely among the currently available products. Making decisions based on the connectors alone can be difficult for clinical staff.2 In addition, several studies looking at intraluminal contamination from the needleless connector have demonstrated that high levels of contamination can be seen colonizing the connector and subsequently moving into the CVC. Even with varying levels of disinfection, colonization can still occur. Further, the epidemiology of gram-negative versus grampositive organisms may require varying rates of disinfection.3 Considering that colonization can occur with disinfection, some consider disinfection unnecessary. Studies of current IV practices demonstrated that 56% of registered nurses typically do not believe it is necessary to disinfect catheter hubs. And >90% of nurses do not cover an intermittent IV infusion.4 Looking back at our central line infection cases, it became increasingly clear that we were potentially having maintenance- or intraluminal-related infections. Evidence of this is also in trials that show significantly high bacterial counts transferred through the valve.5 Therefore, we proceeded with an evaluation of the cap. We chose the Curos Port Protector (Ivera Medical, San Diego, CA) to evaluate. At the initiation of the trial, this was the only cap available that we were aware of. Subsequently, several other products have entered the marketplace. When developing our strategy, we discussed our current practice and the various options available to reduce intraluminal-related issues. Current practice for disinfecting needleless connectors is to clean the hub with an alcohol sponge for 15 seconds. Options were as simple as enhanced education around CVC management to chlorhexidine scrub. After much debate about which direction to pursue, we decided on the Curos cap with 70% isopropyl alcohol. Methods Banner Estrella Medical Center is a 214-bed community hospital offering cardiac surgery, general surgery, orthopedic surgery, and hematologyeoncology services. This facility inserts >1,500 central lines annually, including peripherally inserted central catheters, tunneled caths, and ports. Our study attempted to decrease intraluminal contamination by minimizing the introduction of contaminants through inadequately disinfected needleless connectors. To that end, 2 ICUs had all the CVC and IV tubing needleless connectors covered with a protective cap. This study was done as a nonrandomized prospective trial occurring March 1, 2011 through February 29, 2012. We defined CLABSI according to the Centers for Disease Control and Prevention’s National Healthcare Safety Network guidelines.6 The study was preapproved by hospital administration and critical care committee. The study sample was all the patients in our ICU with an indwelling central line who were receiving IV treatments through the line. The decision to include all patients was made
because the facility had reliable data on CLABSI-related infections for the previous 3 years and because introducing the cap was the only change made to the process of inserting and caring for the lines. No randomization was attempted, the premise being that during the study period the patient mix would be comparable with the patient mix seen during the 3 previous years. The outcomes measure was the CLABSI rate. Statistical methods Unpaired t tests were used to compare the data from the 12 months before the trial start with the 12 months of the trial. The result from the comparison revealed a 2-tailed p value of 0.1260, a mean of 1.525, and a 95% confidence interval of -0.463 to 3.513. The mean of Group One minus Group Two was 1.5250.959 with t22¼1.5906. Although the p value is not considered significant by conventional criteria, we saw a 75% reduction in the number of CLABSIs in our ICU. Intervention Trial design and implementation developed through the critical care service line. Multidisciplinary meetings were conducted emphasizing education on trial design and implementation. Focused education was given to unit registered nurses and respiratory therapists regarding the need to use the cap on all connectors because these professionals share responsibility for CVC maintenance. The simplicity of the product involved in the trial did not necessitate extensive training or pre- and post-testing. Adding connectors or deadend devices to a CVC is a fairly well-established function and is part of the routine care of CVCs. The caps were made readily available in medication rooms. Par levels were maintained at specific levels throughout the trial so no lapses in compliance could occur. A survey tool was also implemented to document compliance with the cap. This tool was utilized throughout the trial during rounding. During each rounding event, the trained observers recorded how many of the connectors were covered by a cap. Observers were uniformly trained in using the form to ensure validity and reliability. Trial compliance or cap use was the biggest challenge; that is, maintaining consistent use of the cap on every access connector. Results During 2010, there were 4 CLABSI-related infections in our ICU. After the trial started (during the period from March 2011 to March 2012), there was 1 catheter-associated blood stream infection. The average monthly number of central line days in 2011 was 180 compared with 176 in 2010, with a high of 208 and a low of 153. The single infection occurred in a patient who experienced a cardiac arrest while in a diagnostic area and had a femoral line emergently inserted. The line could not be removed and was left in place for an extended period of time as the only vascular access for this patient. The CLABSI data were reported to the National Healthcare Safety Network, which resulted in a standardized infection rate change of 1.259 in 2010 to 0.308 in 2011. The CLABSI rate decreased
2012
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j
JAVA
j
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Figure 1. Twenty-two-month incidence of CLABSI and yearly average rate. from 1.9/1,000 catheter days in 2010 down to 0.5/1,000 catheter days in 20117 (Figure 1). The tool developed to monitor compliance was utilized during every rounding event to document adherence to trial by measuring how many of the eligible access sites had a cap in place. Compliance varied from a low of 25% to a high of 100%. If a single IV administration set was being used, it was considered protected or 100% compliant if there was a cap on every needleless connector. If there were additional administration sets or piggybacks, they were included in the compliance rate (Figure 2). Some months into the study, we noted that cap compliance was low. The main barrier identified by users was related to
Figure 2. Percentage of monthly compliance with cap use.
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Figure 3. Compliance variance utilizing single cap vs multiple cap strips.
cap availability at the bedside. A decision was made to add cap strips that could be hung on IV poles in patient rooms. Formalized product education was done concurrently. The strips were added during Month 5 of the trial. The average compliance after adding the strips increased from 63% to 80%. The average compliance throughout the 12-month trial was 73%. Single caps remained an option throughout the trial (Figure 3). Discussion There are several studies available to help understand the various types of intraluminal contamination. Studies on cleaning surfaces with various solutions and durations, best connector, and valved catheters have been conducted. Ultimately, these are all attempts to reduce intraluminal catheter infection. The 70% isopropyl alcohol cap is also an attempt to reduce intraluminal contamination. However, the strategy is different in respect to the cap creating an environment that prevents colonization in the first place. Our 1-year trial resulted in a significant decrease in CLABSIs. A decrease of 1.4/1,000 catheter days from 2010 to 2011 was achieved. A point of interest is the 1 catheter infection identified during the trial was also during the same month with the lowest cap use. Although no direct relationship can be established, they did occur during the same month. Cap use throughout the trial required ongoing training and encouragement to change practice. During the initial 5 months, we used single caps. Utilization rates averaged about 63%. We observed issues with availability and convenience because the nurses and respiratory therapists did not always have the caps readily available. In July, we switched to a different cap package. The currently used caps are available on a strip of 10 that can be conveniently hung on an IV pole. Use increased to an average of 80%. The average overall use during the entire trial came in at 73%. A significant drop in CLABSI was still achieved despite not reaching a higher compliance rate. Over the course of 1 year, the hospital used 37,850 protective connector caps. There was some migration to an oncology
2012
unit where staff members also wanted to use the caps. The exact volume used in the oncology unit was very small in relation to the volume used in our ICU. Cost for the trial was approximately $10,000 (maybe a little less with the uncontrolled cap migration). The Centers for Disease Control and Prevention estimate the cost of CLABSIs is substantial, both in terms of morbidity and financial resources expended. Their estimate is that, on average, hospitals have an increase in patient length of stay by 2 to 5 days for every CLABSI. The attributable cost per CLABSI event is variable, but on average, the estimated cost reported in the literature is $16,350.8 Based on these recognized expense projections and CLABSI reduction, a calculated net savings of $39,050 was realized in this trial. This does not include the additional morbidities associated with CLABSI, including increased mortality, sepsis, thrombus/deep vein thrombosis, multiple catheterizations, and loss of useful vasculature. Conclusions The goal of our trial was to find out if maintaining sterility at the port site using an alcohol-impregnated cap would have an affect on intraluminal catheter-associated blood stream infections in our ICU. Our results indicate that consistent use of the caps in tandem with utilization compliance does influence CLABSI rates.
References 1. Cobb D, High K. A controlled trial of scheduled replacement of central venous and pulmonary-artery catheters. N Engl J Med. 1992;327:1062-1068. 2. Mathers D. Evidence-based practice: improving outcomes for patients with a central venous access device. J Assoc Vasc Access. 2011;16:64-72. 3. Simmons S, Bryson C, Porter S. “Scrub the hub”: cleaning duration and reduction in bacterial load on central venous catheters. Crit Care Nurs Q. 2011;34:31-35. 4. Hadaway L. Intermittent intravenous administration sets: survey of current practices. JAVA. 2011;12:143-147. 5. Ryder M, Fisher S, Hamilton G, et al. Bacterial transfer through needle free connectors: comparison of nine different devices. Poster presented at 2007 Meeting of The Society for Healthcare Epidemiology of America. 6. O’Grady NP, Alexander M, Dellinger EP, et al. Guidelines for the prevention of intravascular catheter-related infections. Centers for Disease Control and Prevention website. http:// www.cdc.gov/hicpac/pdf/guidelines/bsi-guidelines-2011.pdf. Accessed November 5, 2012. 7. National Healthcare Safety Network. Source of aggregate data: NHSN report. Am J Infect Control. 2009;37:783-805. 8. Mermel L. Prevention of intravascular catheter-related infections. Ann Intern Med. 2000;132:391-402.
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