Reduction in IV Associated Contamination

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Reduction in Intraoperative Lumen Contamination of Standard 3-Way Open Lumen Stopcock Sets Through Use of a Novel, Passive Bundle

Conditions
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Post-operative Infections

Intervention / Treatment
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* Device: Passive Bundle PSI (Problem Solving Innovations) Medical HubScrub, PSI Medical DocIt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient undergoing surgery or procedure in operating room Undergoing general anesthesia Exclusion Criteria: Children (age < 18 years) Lack of intravenous access failure of anesthesia provider to complete training on experimental device

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Control arm using standard of care operating room procedures and equipment | |
| Experimental: Problem Solving Innovations (PSI) Experimental<br>Implementation of the passive bundle including HubScrub and DocIt | Device: Passive Bundle PSI (Problem Solving Innovations) Medical HubScrub, PSI Medical DocIt<br>* Implementation of passive bundle which includes HubScrub and DocIt device into the operating room environment.<br>* Other names: PSI Medical DocIt;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | Until positive, up to 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IV contamination, intravenous contamination, stopcock contamination, surgical site infection