Reduction in IV Associated Contamination

• ClinicalTrials.gov Identifier: NCT01426217
• Recruitment Status: Completed
• First Posted: August 31, 2011
• Results First Posted: October 18, 2018
• Last Update Posted: October 18, 2018
• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborator: PSI Medical
• Information provided by (Responsible Party): Dartmouth-Hitchcock Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Post-operative Infections	Device: Passive Bundle PSI (Problem Solving Innovations) Medical HubScrub, PSI Medical DocIt	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 594 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: Reduction in Intraoperative Lumen Contamination of Standard 3-Way Open Lumen Stopcock Sets Through Use of a Novel, Passive Bundle
• Study Start Date: August 2011
• Actual Primary Completion Date: November 2011
• Actual Study Completion Date: November 2011

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control; Control arm using standard of care operating room procedures and equipment
Experimental: Problem Solving Innovations (PSI) Experimental; Implementation of the passive bundle including HubScrub and DocIt	Device: Passive Bundle PSI (Problem Solving Innovations) Medical HubScrub, PSI Medical DocIt; Implementation of passive bundle which includes HubScrub and DocIt device into the operating room environment.; Other Names: PSI Medical HubScrub; PSI Medical DocIt

Outcome Measures

Primary Outcome Measures :

1. Presence of Bacterial IV Stopcock Lumen Contamination [ Time Frame: 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 :

1. Presence of Positive Bacterial Culture in IV Stopcock Due to Effluent Contamination [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, New Hampshire

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

PSI Medical

Investigators

• Principal Investigator: Bryan S Brindeiro, MD; Dartmouth-Hitchcock Medical Center
• Study Director: Randy W Loftus, MD; Dartmouth-Hitchcock Medical Center

More Information

Publications of Results:

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.

Other Publications:

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.

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.

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.

• Responsible Party: Dartmouth-Hitchcock Medical Center
• ClinicalTrials.gov Identifier: NCT01426217
• Other Study ID Numbers: 22743
• First Posted: August 31, 2011
• Results First Posted: October 18, 2018
• Last Update Posted: October 18, 2018
• Last Verified: August 2018

Keywords provided by Dartmouth-Hitchcock Medical Center:

IV contamination; intravenous contamination; stopcock contamination; surgical site infection

Additional relevant MeSH terms:

Infections