Clinical trial NCT03992209: Reducing Intraoperative Infection Transmission in the Pediatric Operating Room
Official title: Reducing Intraoperative ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter Spp.) Transmission In the Pediatric Operating Room Via Use of a Personal Hand Hygiene System Optimized by OR PathTrac
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Care Associated Infection
Hand Hygiene
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of Iowa
First posted: 2019-06-20
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two study arms to include:

1. Standard hand washing by anesthesia provider
2. Protocolized hand washing by anesthesia provider
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. All intraoperative providers at Children's Hospital Colorado will be eligible to participate
2. Pediatric patients age 1-18 years old presenting to the main operating room at Children's Hospital Colorado who will require general anesthesia with placement of a peripheral intravenous catheter.

Exclusion Criteria:

1. Adult patients, age greater than 18 years old
2. Patients without an intravenous catheter

Primary outcomes:
measure: Transmission of pathologic bacteria in the operating room
timeFrame: 6 months
Secondary outcomes:
measure: Baseline pathogen contamination among pediatric surgical patients
timeFrame: 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado Department of Anesthesiology
name: Patrick Fernandez, MD
role: PRINCIPAL_INVESTIGATOR
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