Reduction in IV Associated Contamination

Not Applicable

Completed

Conditions: Post-operative Infections

Interventions: Device: Passive Bundle PSI (Problem Solving Innovations) Medical HubScrub, PSI Medical DocIt

Registration Number: NCT01426217

Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 594

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Problem Solving Innovations (PSI) Experimental	Passive Bundle PSI (Problem Solving Innovations) Medical HubScrub, PSI Medical DocIt	Implementation of the passive bundle including HubScrub and DocIt

Primary Outcome Measures

Name	Time	Method
Presence of Bacterial IV Stopcock Lumen Contamination	48 hours	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

Secondary Outcome Measures

Name	Time	Method
Presence of Positive Bacterial Culture in IV Stopcock Due to Effluent Contamination	Until positive, up to 5 days	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.