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| ID | Type | Description | Link |
|---|---|---|---|
| Study 05-014137 | Other Identifier | 3M |
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| Name | Class |
|---|---|
| Eurotrials Brasil Consultores Cientificos Ltda | INDUSTRY |
| 3M | INDUSTRY |
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Insertion and maintenance of central venous catheter (CVC) lines are common hospital procedures in patients, including those being treated for cancer. CVCs allow clinicians an access point for infusion of fluids, blood sampling, and measurements, decreasing the need for repeated needle sticks to the patient. However, bloodstream infections associated with CVCs (CLABSIs) are a serious complication, leading to significantly longer hospital stays, morbidity, and mortality. Keeping catheter ports disinfected reduces the risk of bloodstream infection; however, consistent and adequate maintenance and disinfection of the line can be difficult.
The purpose of this study is to demonstrate that passive disinfecting caps can provide a patient safety practice that is easy for clinicians to follow, as well as providing easily auditable compliance, which may lead to lower CLABSI rates.
The compliance rate for needleless connector disinfection will be evaluated after implementation of the passive disinfecting cap, and compared to the pre-intervention rate. The CLABSI rates before and after cap implementation will also be compared.
Insertion and maintenance of central venous catheter (CVC) lines are common hospital procedures in patients, including those being treated for cancer. CVCs allow clinicians an access point for infusion of fluids, blood sampling, and measurements, decreasing the need for repeated needle sticks to the patient. However, bloodstream infections associated with CVCs (CLABSIs) are a serious complication, leading to significantly longer hospital stays, morbidity, and mortality. Keeping catheter ports disinfected reduces the risk of bloodstream infection; however, consistent and adequate maintenance and disinfection of the line can be difficult.
The purpose of this study is to demonstrate that passive disinfecting caps can provide a patient safety practice that is easy for clinicians to follow, as well as providing easily auditable compliance, which may lead to lower CLABSI rates.
Compliance is defined as following the protocol for disinfection of the catheter port. In the pre-intervention period, the disinfection protocol will utilize existing institution scrub-the-hub method. Compliance in the pre-intervention period will be determined by survey.
After the pre-intervention period is complete, passive disinfecting devices (caps) will be implemented hospital-wide for any adult patient using CVC ports.
In the intervention period, the disinfection protocol consists of using the disinfecting barrier cap on every needless connector (catheter port) used for accessing CVC IV lines per protocol. Compliance will be measured using observations, according to a schedule to ensure the absence of a shift bias. Observations will contain the number of needless connectors on CVCs with, and the number of needleless connectors without, disinfecting barrier caps attached.
The compliance rate for needleless connector disinfection will be evaluated after implementation of the passive disinfecting cap, and compared to the pre-intervention rate. The CLABSI rates before and after cap implementation will also be compared.
Incidence of CLABSI will be noted from existing aggregate hospital surveillance system data. The incidence, in terms of catheter days, will be recorded for each assigned intervention ward and for intervention ward overall by month, in the six months before the intervention and in the six-month intervention recording period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Disinfecting barrier cap | Other | In the participating wards, disinfecting barrier cap was used on every needless connector used for accessing CVC IV lines. Compliance with disinfecting barrier cap was observed weekly. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Passive disinfection device | Device | Add use of passive disinfection cap to existing central line needleless connector infection control procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| Disinfecting Barrier Cap Compliance | Compliance to disinfection protocol for central line needleless connectors. Compliance will be measured by periodic audits, where the number of disinfecting caps on central line needleless connectors is compared to the total number of central line needleless connectors to determine compliance percentage. | 6-month prospective period |
| Scrub the Hub Protocol Compliance | Compliance with Scrub the hub protocol Data collected retrospectively by survey | 6-month retrospective period |
| Measure | Description | Time Frame |
|---|---|---|
| CLABSI Rate | Central-line associated blood stream infection assessments were performed once a month per ward during the pre-intervention and post-intervention periods. The total number of CLABSI infections and CVC/day were recorded in all assessments to determine the CLABSI rate per 1000 CVC/days. Infections from patients without CVC IV access (those using a three-lumen dialysis catheter with a needleless connector on the third lumen and those using two-lumen dialysis catheters) were also recorded as part of the aggregated data, due to the impossibility of separating the infections in these patients from the ones with CVC access |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo A Zimerman, MD | Irmandade da Santa Casa de Misericordia de Porto Alegre - ISCMPA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 3M HealthCare | Maplewood | Minnesota | 55144 | United States |
No individual participant data will be recorded in the study.
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No individual patient was recruited into the study.
| ID | Title | Description |
|---|---|---|
| FG000 | Compliance With Scrub the Hub Protocol | Compliance with scrub the hub protocol was retrospectively measured through a survey from Health care workers who were working in the hospital and used needleless connector |
| FG001 | Compliance With Disinfecting Barrier Cap Ptotocol | In the participating wards, disinfecting barrier cap was used on every needless connector used for accessing CVC IV lines. Compliance with disinfecting barrier cap was observed weekly. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline data were not collected for the health care workers. No individual patient was consented in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Not Applicable | During the study, Baseline data were not collected for the health care workers. No individual patient was consented in the study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Not Available. Baseline data were not collected for the health care workers. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Disinfecting Barrier Cap Compliance | Compliance to disinfection protocol for central line needleless connectors. Compliance will be measured by periodic audits, where the number of disinfecting caps on central line needleless connectors is compared to the total number of central line needleless connectors to determine compliance percentage. | No patients assessed for disinfecting barrier cap compliance. Compliance with disinfecting barrier cap was measured by observation of numbers of applicable capped, uncapped ports and misused caps. A total of 156 audits were performed. | Posted | Mean | Standard Deviation | percentage of connector with compliance | 6-month prospective period | Compliance audits | Compliance audits |
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No individual patient data (including adverse events [AEs]) were recorded during this study.
No individual patient data (including adverse events [AEs]) were recorded during this study as no individual patient was enrolled into the study .
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No individual patient data (including adverse events [AEs]) were recorded during this study. |
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The rate of CLABSI per 1000 central line days was determined by using aggregated data on infections and on CVC/day during the study period. Infections from patients without CVC IV access were also part of the aggregated data recorded. However, as these patients did not have CVC access, they did not contribute to the CVC/day data collected throughout the study. As a result, the rate of CLABSI may have been overestimated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Helen Han | 3M | 651-737-9234 | mhan3@mmm.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 28, 2019 | Feb 22, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 24, 2019 | Feb 22, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003428 | Cross Infection |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| 6-month retrospective period and 6-month prospective period |
| Catheter-associated Urinary Tract Infection (CAUTI) Rate | Rate of CAUTI per 1000 indwelling urinary catheter days. CAUTI data was recorded to control for possible seasonal and/or environmental effects that could also influence CLABSI and hospital infection rates overall. Data on this type of infection was only available for the ICU, as recording of CAUTI is only mandatory in the intensive care setting in Brazil. | 6 months pre-intervention and 6 months post intervention |
| Ventilator-associated Pneumonia (VAP) Rate | Rate of VAP per 1000 ventilator days. VAP data was recorded to control for possible seasonal and/or environmental effects that could also influence CLABSI and hospital infection rates overall. Data on this type of infection was only available for the ICU, as recording of VAP is only mandatory in the intensive care setting in Brazil. | 6-month retrospective period and 6-month prospective period |
| MBI-Related CLABSI Rate | Central-line associated blood stream infection assessments were performed once a month per ward during the pre-intervention and post-intervention periods. The total number of CLABSI infections and CVC/day were recorded in all assessments. Lastly, CLABSIs were divided into mucosal-barrier injury (MBI)-related and non-MBI-related and recorded separately in the eCRF. MBI-related CLABSIs and CVC/day were used to determine MBI CLABSI rate per 1000 CVC/days. Infections from patients without CVC IV access (those using a three-lumen dialysis catheter with a needleless connector on the third lumen and those using two-lumen dialysis catheters) were also recorded as part of the aggregated data, due to the impossibility of separating the infections in these patients from the ones with CVC access. | 6-month retrospective period and 6-month prospective period |
| Non MBI-related CLABSI Rate | Central-line associated blood stream infection assessments were performed once a month per ward during the pre-intervention and post-intervention periods. The total number of CLABSI infections and CVC/day were recorded in all assessments. Lastly, CLABSIs were divided into mucosal-barrier injury (MBI)-related and non-MBI-related and recorded separately in the eCRF. Non MBI-related CLABSIs and CVC/day were used to determine Non-MBI CLABSI rate per 1000 CVC/days. Infections from patients without CVC IV access (those using a three-lumen dialysis catheter with a needleless connector on the third lumen and those using two-lumen dialysis catheters) were also recorded as part of the aggregated data, due to the impossibility of separating the infections in these patients from the ones with CVC access. | 6-month retrospective period and 6-month prospective period |
| Sex: Female, Male | Measure Description: Not Available. Baseline data were not collected for the health care workers. |
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| Race (NIH/OMB) | Measure Description: Not Available. Baseline data were not collected for the health care workers. |
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| Study-Specific Measure | Measure Description: Not Available. Baseline data were not collected for the health care workers. |
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| Primary | Scrub the Hub Protocol Compliance | Compliance with Scrub the hub protocol Data collected retrospectively by survey | Compliance with scrub the hub was retrospectively obtained by a survey from 165 healthcare workers who were using needlessness connectors for patient IV access. One was excluded from the compliance analysis due to an inconsistency in the survey data. No patients assessed for disinfecting barrier cap compliance. | Posted | Mean | Standard Deviation | percentage of protocol compliance | 6-month retrospective period |
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| Secondary | CLABSI Rate | Central-line associated blood stream infection assessments were performed once a month per ward during the pre-intervention and post-intervention periods. The total number of CLABSI infections and CVC/day were recorded in all assessments to determine the CLABSI rate per 1000 CVC/days. Infections from patients without CVC IV access (those using a three-lumen dialysis catheter with a needleless connector on the third lumen and those using two-lumen dialysis catheters) were also recorded as part of the aggregated data, due to the impossibility of separating the infections in these patients from the ones with CVC access | Patients who require needleless connectors for CVC IV access or dialysis catheters in one ICU (6 units) and five non-ICU (6 units of each) wards. Total 36 units. No individual patients were enrolled in this study. No Patients assessed for this measure. | Posted | Number | CLABSI rate per 1000 catheter days | 6-month retrospective period and 6-month prospective period | ICU and non-ICU wards | ICU and non-ICU wards |
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| Secondary | Catheter-associated Urinary Tract Infection (CAUTI) Rate | Rate of CAUTI per 1000 indwelling urinary catheter days. CAUTI data was recorded to control for possible seasonal and/or environmental effects that could also influence CLABSI and hospital infection rates overall. Data on this type of infection was only available for the ICU, as recording of CAUTI is only mandatory in the intensive care setting in Brazil. | Infections from patients with indwelling urinary catheters in one ICU ward. Total 6 units. No individual patients were enrolled in this study. No patients assessed for this measure. | Posted | Number | CAUTI rate per 1000 catheter days | 6 months pre-intervention and 6 months post intervention | Units in ICU ward | Units in ICU ward |
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|
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| Secondary | Ventilator-associated Pneumonia (VAP) Rate | Rate of VAP per 1000 ventilator days. VAP data was recorded to control for possible seasonal and/or environmental effects that could also influence CLABSI and hospital infection rates overall. Data on this type of infection was only available for the ICU, as recording of VAP is only mandatory in the intensive care setting in Brazil. | Infections from patients who have been intubated and received mechanical ventilation in one ICU ward (6 units). No Patients assessed for this measure. | Posted | Number | VAP rate per 1000 ventilator days | 6-month retrospective period and 6-month prospective period | Units in ICU ward | Units in ICU ward |
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|
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| Secondary | MBI-Related CLABSI Rate | Central-line associated blood stream infection assessments were performed once a month per ward during the pre-intervention and post-intervention periods. The total number of CLABSI infections and CVC/day were recorded in all assessments. Lastly, CLABSIs were divided into mucosal-barrier injury (MBI)-related and non-MBI-related and recorded separately in the eCRF. MBI-related CLABSIs and CVC/day were used to determine MBI CLABSI rate per 1000 CVC/days. Infections from patients without CVC IV access (those using a three-lumen dialysis catheter with a needleless connector on the third lumen and those using two-lumen dialysis catheters) were also recorded as part of the aggregated data, due to the impossibility of separating the infections in these patients from the ones with CVC access. | Patients who require needleless connectors for CVC IV access or dialysis catheters in one ICU (6 units) and five non-ICU (6 units of each) wards. Total 36 units. No individual patients were enrolled in this study. No Patients assessed for this measure. | Posted | Number | MBI CLABSI rate per 1000 catheter days | 6-month retrospective period and 6-month prospective period | ICU and non-ICU wards | ICU and non-ICU wards |
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| Secondary | Non MBI-related CLABSI Rate | Central-line associated blood stream infection assessments were performed once a month per ward during the pre-intervention and post-intervention periods. The total number of CLABSI infections and CVC/day were recorded in all assessments. Lastly, CLABSIs were divided into mucosal-barrier injury (MBI)-related and non-MBI-related and recorded separately in the eCRF. Non MBI-related CLABSIs and CVC/day were used to determine Non-MBI CLABSI rate per 1000 CVC/days. Infections from patients without CVC IV access (those using a three-lumen dialysis catheter with a needleless connector on the third lumen and those using two-lumen dialysis catheters) were also recorded as part of the aggregated data, due to the impossibility of separating the infections in these patients from the ones with CVC access. | Patients who require needleless connectors for CVC IV access or dialysis catheters in one ICU (6 units) and five non-ICU (6 units of each) wards. Total 36 units. No individual patients were enrolled in this study. No Patients assessed for this measure. | Posted | Number | CLABSI rate per 1000 catheter days | 6-month retrospective period and 6-month prospective period | ICU and non-ICU wards | ICU and non-ICU wards |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |