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| Name | Class |
|---|---|
| PSI Medical | UNKNOWN |
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The purpose of this study is to investigate whether implementing a novel syringe and IV stopcock cap system impregnated with alcohol will reduce IV catheter bacterial contamination and infections in patients.
Bacterial contamination of patient intravenous stopcock sets is a common intraoperative event associated with increased patient mortality, possibly via an infectious mechanism. The most common type of intravenous tubing used in operating rooms is the open lumen stopcock set which lacks a barrier between the environment and intraluminal space, and thus the intravascular space of the patient. The stopcock connector can be easily contaminated by provider hands due to improper handling of the device and/or contaminated by soiled syringe tips subsequently connected to the device. Further, the stopcock connector is often left uncapped by the provider and directly exposed to the environment. Thus, common breaches in intraoperative aseptic practice of healthcare providers can lead to bacterial contamination of the endoluminal space of the open lumen device. The primary aim of the current study is to assess the efficacy of a passive bundle designed to decrease intravenous stopcock and tubing intraluminal bacterial contamination. This passive bundle includes two novel interventions, a DOCit station and HubScrub caps. The HubScrub is designed to clean the needleless connectors and open lumen stopcock systems. The DOCit station is designed to simultaneously clean the interior and exterior of needle-less luer connectors of syringes with isopropyl alcohol while also providing a method of storage and organization of multiple syringes. The investigators hypothesize that the application of this passive bundle to the standard open lumen system commonly employed by anesthesia providers in the operating room will significantly reduce bacterial contamination of standard 3-way open lumen stopcock sets and improve patient safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Control arm using standard of care operating room procedures and equipment | |
| Problem Solving Innovations (PSI) Experimental | Experimental | Implementation of the passive bundle including HubScrub and DocIt |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Passive Bundle PSI (Problem Solving Innovations) Medical HubScrub, PSI Medical DocIt | Device | Implementation of passive bundle which includes HubScrub and DocIt device into the operating room environment. |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Bacterial IV Stopcock Lumen Contamination | The presence of bacteria in the stopcock lumen was assessed by analyzing swab cultures of the lumens. Each swab potentially containing bacteria from any of the 3 lumens of the stopcock sets were analyzed | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Positive Bacterial Culture in IV Stopcock Due to Effluent Contamination | Open lumen ports were removed from the patient; sent directly to the anesthesiology microbiology laboratory; connected by the same clinical laboratory scientist to sterile catheters using sterile, aseptic technique; and injected directly into a BacT/Alert 3D system (bioMérieux Inc., Durham, NC) with 2 mL of sterile saline per port. BacT/Alert is a blood culture system that automatically monitors bacterial growth using colorimetry; a sensor inserted at the bottom of the bottle changes color on detecting the carbon dioxide produced by the growth of the bacteria. Catheters were then removed, and the bottles were directly incubated in the BacT/Alert system for 5 days or until positive. Once positive, the liquid in the bottle was examined to identify the organism. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bryan S Brindeiro, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Randy W Loftus, MD | Dartmouth-Hitchcock Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20686007 | Background | Loftus RW, Muffly MK, Brown JR, Beach ML, Koff MD, Corwin HL, Surgenor SD, Kirkland KB, Yeager MP. Hand contamination of anesthesia providers is an important risk factor for intraoperative bacterial transmission. Anesth Analg. 2011 Jan;112(1):98-105. doi: 10.1213/ANE.0b013e3181e7ce18. Epub 2010 Aug 4. | |
| 19352154 | Background |
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The study was conducted over 3-month period (Aug 1, 2011 to Nov 8, 2011) at Dartmouth-Hitchcock Medical Center, a tertiary care and level 1 trauma center in New Hampshire with 400 inpatient beds and 28 operating suites. The operating rooms enrolled during the study period were randomly selected on a daily basis from the available 28 operating rooms
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Control arm using standard of care operating room procedures and equipment. |
| FG001 | Experimental Group | Implementation of passive bundle which includes HubScrub and DOCIt device into the operating room environment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Control arm using standard of care operating room procedures and equipment |
| BG001 | Experimental Group | Implementation of passive bundle which includes HubScrub and DocIt device into the operating room environment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Presence of Bacterial IV Stopcock Lumen Contamination | The presence of bacteria in the stopcock lumen was assessed by analyzing swab cultures of the lumens. Each swab potentially containing bacteria from any of the 3 lumens of the stopcock sets were analyzed | Posted | Number | percent stopcock contamination rate | 48 hours | Operating Rooms | Operating Rooms |
|
30 days
Experimental & Control groups were combined for analysis. Sincere efforts were made to gather & report data, however, no specific data for each group is available.
Events:
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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 | Entire Population | Experimental and Control groups were combined for analysis. Control arm used standard of care operating room procedures and equipment. Experimental arm implemented a of passive bundle which includes HubScrub and DocIt device into the operating room environment. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HCAI | Infections and infestations | Systematic Assessment | Healthcare associated infections (HCAI) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Randy Loftus, MD | Dartmouth-Hitchcock Medical Center | (603) 650-6177 | Randy.W.Loftus@hitchcock.org |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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|
| Until positive, up to 5 days |
| Koff MD, Loftus RW, Burchman CC, Schwartzman JD, Read ME, Henry ES, Beach ML. Reduction in intraoperative bacterial contamination of peripheral intravenous tubing through the use of a novel device. Anesthesiology. 2009 May;110(5):978-85. doi: 10.1097/ALN.0b013e3181a06ec3. |
| 18719437 | Background | Loftus RW, Koff MD, Burchman CC, Schwartzman JD, Thorum V, Read ME, Wood TA, Beach ML. Transmission of pathogenic bacterial organisms in the anesthesia work area. Anesthesiology. 2008 Sep;109(3):399-407. doi: 10.1097/ALN.0b013e318182c855. |
| 23144441 | Result | Loftus RW, Brindeiro BS, Kispert DP, Patel HM, Koff MD, Jensen JT, Dodds TM, Yeager MP, Ruoff KL, Gallagher JD, Beach ML, Brown JR. Reduction in intraoperative bacterial contamination of peripheral intravenous tubing through the use of a passive catheter care system. Anesth Analg. 2012 Dec;115(6):1315-23. doi: 10.1213/ANE.0b013e31826d2aa4. Epub 2012 Nov 9. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Presence of Positive Bacterial Culture in IV Stopcock Due to Effluent Contamination | Open lumen ports were removed from the patient; sent directly to the anesthesiology microbiology laboratory; connected by the same clinical laboratory scientist to sterile catheters using sterile, aseptic technique; and injected directly into a BacT/Alert 3D system (bioMérieux Inc., Durham, NC) with 2 mL of sterile saline per port. BacT/Alert is a blood culture system that automatically monitors bacterial growth using colorimetry; a sensor inserted at the bottom of the bottle changes color on detecting the carbon dioxide produced by the growth of the bacteria. Catheters were then removed, and the bottles were directly incubated in the BacT/Alert system for 5 days or until positive. Once positive, the liquid in the bottle was examined to identify the organism. | Specific data for each arm can not be obtained. Sincere efforts were made to obtain and report the data, however, no data is available. | Posted | Number | cases of effluent contamination | Until positive, up to 5 days |
|
|
|
|
| 0 |
| 572 |
| 0 |
| 572 |
| 86 |
| 572 |
|
| Phlebitis | Vascular disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |