Reduction in IV Associated Contamination

Dartmouth Health

Status: Completed

Conditions: Post-operative Infections

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01426217

22743

Details and patient eligibility

About

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.

Full 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.

Enrollment: 594 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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594 participants in 2 patient groups

Control

No Intervention group

Description:

Control arm using standard of care operating room procedures and equipment

Problem Solving Innovations (PSI) Experimental

Experimental group

Description:

Implementation of the passive bundle including HubScrub and DocIt

Treatment:

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