Reducing Intraoperative Infection Transmission in the Pediatric Operating Room
Condition: Health Care Associated Infection; Hand Hygiene
MeSH terms: Infections; Cross Infection
Study type: Interventional

Summary: 
      Patients becoming infected during hospitalization occurs frequently and causes harm. It is
      important for healthcare facilities to take action to prevent these infections and their
      spread between patients. Despite the presumption of a "sterile" environment, one place where
      spread of infection is known to happen is in the operating room. This occurs as a result of
      frequent interaction among healthcare providers, the patient and the environment of the room.
      Hand washing is an important component of preventing the spread of infections. Scientific
      evidence has shown that making it easier for people to wash their hands can have two
      important impacts: (1) reduction of environmental bacterial contamination and (2) reduction
      in spread of bacterial pathogens. OR PathTrac is new technology that allows tracking of
      bacterial spread. While data exists about bacterial contamination and transmission in the
      adult operating room, there is very minimal data about this in the pediatric operating room.
      Primary aim: To use OR PathTrac to evaluate the effect of a personal hand washing device in
      reducing operating room exposure to bacterial pathogens in pediatric patients. We hypothesize
      that this hand washing system will decrease exposure to pathologic bacteria in the pediatric
      operating room. Secondary aim: To gain knowledge about baseline bacterial contamination and
      transmission in pediatric operating rooms. We will answer this question by comparing
      bacterial cultures taken from operating rooms whose personnel are trained to use the hand
      washing device to operating rooms who are not trained to use the device.
    

Detailed description: 
      I. Hypotheses: The investigators hypothesize that the use of a personal hand hygiene system
      by anesthesia providers in the OR, combined with a novel infectious pathogen tracking system
      will decrease patient exposure to pathologic bacteria in the pediatric operating room.

      Primary aim: To use a novel pathogen tracking system (OR PathTrac) to evaluate the effect of
      a personal hand hygiene device in reducing operating room exposure to bacterial pathogens in
      pediatric patients.

      Secondary aim: To gain knowledge about the baseline bacterial contamination and transmission
      patterns in pediatric operating rooms.

      II. Background and Significance:

      Healthcare-associated infections (HAIs) occur frequently and are associated with patient
      harm. These infections are becoming more difficult to treat due to antibiotic resistance. It
      is important that healthcare facilities take the necessary steps to prevent the spread of
      resistant bacteria between patients. ESKAPE bacteria (Enterococcus, S. aureus , Klebsiella,
      Acinetobacter, Pseudomonas, and Enterobacter spp.) are particularly problematic because they
      have a unique capacity to acquire resistance traits.8 Isolation of these organisms from
      intraoperative reservoirs has been associated with postoperative infection development.

      Many provider-environment-patient interactions occur during routine care in the operating
      room and must be considered in the development of a successful infection control program.
      Peaks in environmental contamination that exceed 100 CFU, a threshold associated with
      high-risk bacterial transmission events repeatedly associated with increased patient
      mortality and infection, 15 occur during induction and emergence of anesthesia. In turn,
      these high task density periods correlate with nadirs in hand hygiene (HH) compliance (1.8%
      HH compliance during induction with 147 environmental CFU and 2.3% HH compliance during
      emergence with 103 environmental CFU). This work led us to hypothesize that an important
      consideration for improved OR HH was proximity to the provider.

      An intraoperative HH improvement strategy leveraged proximity to the provider and increased
      provider HH rates 27-fold as compared to those achieved with conventional wall-mounted
      devices (P < 0.002; 95% confidence interval, 3.3-13.4). Increased HH reduced environmental
      contamination below 100 CFU (78 fewer colonies per surface sampled; P =0.01). In turn, high
      risk bacterial transmission events were decreased (32.8% control vs. 7.5% treatment, OR,
      0.17; P <0.01), and postoperative HAIs [3.8% treatment vs. 17.2% control, OR 0.19, 95% CI
      0.00-0.81, P=0.02, NNT 5.7, including bloodstream, respiratory, urinary tract, and surgical
      site infections] were reduced.

      Much of the aforementioned data has been established in adult operating room patients, there
      is very little knowledge about this as it pertains to the pediatric operating room. The
      investigators plan to use a similar evidence-based, hand hygiene improvement strategy to
      reduce intraoperative transmission of ESKAPE pathogens in the pediatric operating room. After
      watching a 20-minute instructional video discussing the importance adhering to the many hand
      hygiene opportunities in the operating room, anesthesia providers will be given a personal
      hand hygiene device with actionable real-time performance feedback containing 64% ethyl
      alcohol. The personalized device will be affixed to the provider's waist and will remain
      there for use throughout the entire case. The number of personal hand hygiene events and a
      personal hourly hand hygiene rate is visible to the individual providing performance feedback
      in real time. Devices will be handed out for the case and retrieved on case completion.

      The investigators will utilize OR PathTrac, a systematic reservoir collection and software
      analysis platform, to examine the impact of the device on ESKAPE pathogens. The OR PathTrac
      system will provide the platform for acquisition of ESKAPE isolates from key reservoirs in
      the operating room. Systematic phenotypic analysis guided by OR PathTrac will identify
      epidemiologically related isolates. Related isolates are defined by previously reported
      thresholds, 12 aligned by temporal association (the reservoir order of collection over time),
      and mapped to identify bacterial source(s) of transmission. Source identification provides a
      feedback loop that can be used for proactive optimization of infection control measures. For
      example, anesthesia resident physician hands are proven to be a typical source of
      transmission for desiccation tolerant S. aureus isolates that are linked to infection. In the
      future, this evidence can then be used to proactively optimize the hand hygiene improvement
      strategy through individual and group level feedback. The OR PathTrac software platform can
      subsequently measure and report the effectiveness (fidelity) of the improvements, allowing
      for proactive optimization to achieve sustainability.

      III. Research Methods

      A. Outcome Measure(s):

      Primary outcome measure: The primary endpoint of this study will be the incidence of OR
      ESKAPE exposure/S. aureus ERTEs with and without the hand hygiene intervention in the
      pediatric OR.

      Secondary outcome measure: Detection and mapping of intraoperative ESKAPE exposure as it
      pertains to the pediatric operating room.

      B. Description of Population to be Enrolled:

      This study will include anesthesia providers and pediatric patients, age 1-18 years old,
      presenting to the main operating room at Children's Hospital Colorado. All, anesthesia
      providers at Children's Hospital Colorado will be eligible. Patients requiring general
      anesthesia and placement of a peripheral intravenous catheter will be enrolled.

      C. Study Design and Research Methods

      Two patients (case pair) undergoing general anesthesia in a randomly selected operating room
      will be evaluated in a serial manner in order to detect transmission of pathogenic bacteria.
      A total of 20 case pairs (or 40 patients) will be enrolled. Ten of the case pairs will serve
      as the intervention group in which the anesthesia provider will be given a personal hand
      hygiene device to track hand hygiene in real-time. The remaining 10 case pairs will serve as
      a control group for whom the anesthesia providers will proceed with care per usual practice.
      Patient care will not change due to their participation in this study, and they will undergo
      general anesthesia and surgery according to usual practice. Patients will not be asked to
      perform any tasks for the purpose of the study. The following information will be recorded on
      the day of surgery:

        1. Patients name, case log ID, medical record number. These will be maintained by the
           research team for approximately 30 days after surgery.

        2. Date of surgery, whether it is 1st case vs. 2nd case.

        3. Patient diagnosis, ASA (American Society of Anesthesiologists) physical health
           classification status, age, comorbidities, surgery type & duration, anesthesia provided
           and duration of anesthesia.

        4. Attending Anesthesiologist name with patient case ID log.

        5. Wound classification

        6. Admitted from (location i.e.: home, unit, etc)

      Microbiology cultures will be obtained from three intraoperative reservoirs (patient,
      anesthesia provider, anesthesia workspace) for each case. Anesthesia induction will occur
      prior to obtaining patient cultures. A sterile nasal swab will be inserted gently into the
      internal surface of each nostril & rotated 10 times to culture. In addition, a sterile swab
      will be inserted gently into the axilla (armpit) and groin of each patient bilaterally &
      rotated 10 times to culture.

      Cultures of the anesthesia provider's hands will be done prior to the case beginning, at the
      end of the case, and any time they return to the operating room. To collect samples for
      culture, the provider will be asked to dip their dominant hand into a bag containing sterile
      sampling solution for 60 seconds. All intraoperative anesthesia providers will potentially be
      involved. Only those providers who agree to participate will have a culture collected.

      Three cultures from the anesthesia workspace (2 from the anesthesia machine and one from the
      patient's intravenous catheter tubing) will be cultured.

        1. APL Valve and Agent Dial Culture

           For case 1-prior to anesthesia care provider entering the OR, 2 sites on the anesthesia
           machine (adjustable pressure limiting (APL) valve complex & agent dial) will be
           decontaminated & cultured aseptically. A repeat culture will be obtained at the end of
           the case. For Case 2, the APL valve and agent dial will not be decontaminated but will
           be cultured as in case 1.

        2. IV Stopcock Culture

      Sterile intravenous stopcock sets will be provided preoperatively for each case. The internal
      lumens of the stopcocks will be cultured on case completion. Microbiology cultures will be
      obtained by the research team on the day of surgery for each case 1 & case 2. Each culture
      will be given a study ID & transported to the RDB Bioinformatics laboratory (RDB
      Bioinformatics, University of Iowa Bioventures Center, 2500 Cross Park Rd, E133, Coralville,
      IA 52241) at the end of the day using IATA shipping protocols for microbiology assay. No
      patient or anesthesia care provider information will accompany the samples, and no culture
      results will be conveyed to the study team. This will ensure that no culture results for a
      specific person will be known by any study team member. A total of 13 cultures will be
      obtained from each case for a total of 520 cultures for this study.

      D. Description, Risks and Justification of Procedures and Data Collection Tools:

      This study presents no more than minimal risk to the participants.

      Data Collection Tools:

        -  Reservoir sampling: OR PathTrac (RDB Bioinformatics, Omaha, NE 68154) collection kits
           will be used to sample 13 proven reservoirs in each operating room observational unit
           that is randomly selected for analysis. Reservoirs sampled will include the adjustable
           pressure-limiting valve and agent dial of the anesthesia machine at case start and at
           case end (N=2), anesthesia attending physician and primary assigned assistant (resident
           physician or certified-registered nurse anesthetist) hands before case start and at case
           end (N=4), the patient nares (both sides), axilla (armpit, both sides), and groin (both
           sides) after induction and stabilization and at case end prior to emergence (N=6), and
           the surface of the closed, disinfectable stopcock and/or internal lumen of the open
           lumen (N=1).

        -  Demographics: OR number, date, patient age, sex, American Society of Anesthesia (ASA)
           physical health classification status (I-IV), anesthesia duration (hours), procedure
           duration (hours), total case duration (hours), comorbidities, preoperative location
           (same day admit, hospital floor, intensive care unit, other), preadmission yes/no,
           duration of preadmission (hours), discharge location (post anesthesia care unit,
           hospital floor, same day unit, intensive care unit, other), dirty or infected surgery
           yes/no, type of surgery (general abdominal, thoracic, cardiac, general breast, plastics,
           gynecology/oncology, vascular, etc.), prophylactic antibiotic (yes/no), type of
           antibiotic and dose, preoperative nasal decolonization (yes/no), type decolonization
           (povidone iodine, mupirocin, other), days of decolonization, preoperative chlorhexidine
           (yes/no), concentration and days of chlorhexidine, intraoperative mean and median
           temperature, postoperative glucose (or other) in mg/dL if measured, surgical provider
           (assign a code for de-identification), anesthesia provider(s) with de-identified code,
           postoperative unit location (e.g. 3120 west unit), and same day unit location (e.g. same
           day room 31).

        -  Postoperative (within 30 days) elevated white blood cell count yes/no, fever (>38.4
           degrees Celsius yes/no), office documentation of infection (yes/no), anti-infective
           order yes/no, culture positive yes/no, type of culture (sputum, wound, blood, urine,
           other body fluid). This information will be obtained by chart review by the assistant
           before and after the procedure.
    

Intervention name(s): Standard care; Protocolized care
Intervention type(s): Other; Other
Intervention description(s): Usual operating room practice; Hand washing per protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two study arms to include:
Standard hand washing by anesthesia provider
Protocolized hand washing by anesthesia provider
Masking: Single (Outcomes Assessor)
Primary purpose: Other