Reducing Intraoperative Infection Transmission in the Pediatric Operating Room

NCT03992209 | Completed

• 1 other identifier: 19-0759
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Care Associated Infection; Hand Hygiene

Outcome Measures

Primary Outcomes (1)

• Transmission of pathologic bacteria in the operating room

  We will use a novel bioinformatics system to track pathogen transmission in the operating room between anesthesia providers, the anesthesia environment and patients.

  6 months

Secondary Outcomes (1)

• Baseline pathogen contamination among pediatric surgical patients

  6 months

Study Arms (2)

Standard handwashing by anesthesia provider

OTHER

Anesthesia provider will conduct patient care per their usual standard practice in the operating room.

Other: Standard care

Protocolized hand washing by anesthesia provider

ACTIVE COMPARATOR

Anesthesia provider will conduct patient care using a personal hand washing device to optimize hand washing and captures hand washing events in real time.

Other: Protocolized care

Interventions

Standard care OTHER

Usual operating room practice

Standard handwashing by anesthesia provider

Protocolized care OTHER

Hand washing per protocol

Protocolized hand washing by anesthesia provider

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All intraoperative providers at Children's Hospital Colorado will be eligible to participate
• 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.

You may not qualify if:

• Adult patients, age greater than 18 years old
• Patients without an intravenous catheter

Sponsors & Collaborators

• University of Colorado, Denver: lead
• University of Iowa: collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (20)

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  PMID: 30380384 BACKGROUND

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  PMID: 19035777 BACKGROUND

• Loftus RW, Koff MD, Brown JR, Patel HM, Jensen JT, Reddy S, Ruoff KL, Heard SO, Yeager MP, Dodds TM. The epidemiology of Staphylococcus aureus transmission in the anesthesia work area. Anesth Analg. 2015 Apr;120(4):807-18. doi: 10.1213/ANE.0b013e3182a8c16a.

  PMID: 24937345 BACKGROUND

• Loftus RW, Dexter F, Robinson ADM. High-risk Staphylococcus aureus transmission in the operating room: A call for widespread improvements in perioperative hand hygiene and patient decolonization practices. Am J Infect Control. 2018 Oct;46(10):1134-1141. doi: 10.1016/j.ajic.2018.04.211. Epub 2018 Jun 12.

  PMID: 29907449 BACKGROUND

• Loftus RW, Dexter F, Robinson ADM, Horswill AR. Desiccation tolerance is associated with Staphylococcus aureus hypertransmissibility, resistance and infection development in the operating room. J Hosp Infect. 2018 Nov;100(3):299-308. doi: 10.1016/j.jhin.2018.06.020. Epub 2018 Jun 30.

  PMID: 29966756 BACKGROUND

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  PMID: 11136954 BACKGROUND

• Hadder B, Patel HM, Loftus RW. Dynamics of intraoperative Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter transmission. Am J Infect Control. 2018 May;46(5):526-532. doi: 10.1016/j.ajic.2017.10.018. Epub 2018 Feb 12.

  PMID: 29395508 BACKGROUND

• 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.

  PMID: 18719437 BACKGROUND

• Rowlands J, Yeager MP, Beach M, Patel HM, Huysman BC, Loftus RW. Video observation to map hand contact and bacterial transmission in operating rooms. Am J Infect Control. 2014 Jul;42(7):698-701. doi: 10.1016/j.ajic.2014.02.021.

  PMID: 24969122 BACKGROUND

• 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.

  PMID: 19352154 BACKGROUND

• 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.

  PMID: 20686007 BACKGROUND

• Loftus RW, Brown JR, Koff MD, Reddy S, Heard SO, Patel HM, Fernandez PG, Beach ML, Corwin HL, Jensen JT, Kispert D, Huysman B, Dodds TM, Ruoff KL, Yeager MP. Multiple reservoirs contribute to intraoperative bacterial transmission. Anesth Analg. 2012 Jun;114(6):1236-48. doi: 10.1213/ANE.0b013e31824970a2. Epub 2012 Mar 30.

  PMID: 22467892 BACKGROUND

• Loftus RW, Patel HM, Huysman BC, Kispert DP, Koff MD, Gallagher JD, Jensen JT, Rowlands J, Reddy S, Dodds TM, Yeager MP, Ruoff KL, Surgenor SD, Brown JR. Prevention of intravenous bacterial injection from health care provider hands: the importance of catheter design and handling. Anesth Analg. 2012 Nov;115(5):1109-19. doi: 10.1213/ANE.0b013e31826a1016. Epub 2012 Oct 9.

  PMID: 23051883 BACKGROUND

• 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.

  PMID: 23144441 BACKGROUND

• Clark C, Taenzer A, Charette K, Whitty M. Decreasing contamination of the anesthesia environment. Am J Infect Control. 2014 Nov;42(11):1223-5. doi: 10.1016/j.ajic.2014.07.016. Epub 2014 Oct 30.

  PMID: 25444268 BACKGROUND

• Dancer SJ, Stewart M, Coulombe C, Gregori A, Virdi M. Surgical site infections linked to contaminated surgical instruments. J Hosp Infect. 2012 Aug;81(4):231-8. doi: 10.1016/j.jhin.2012.04.023. Epub 2012 Jun 15.

  PMID: 22704634 BACKGROUND

• Fernandez PG, Dexter F, Brown J, Whitney G, Koff MD, Cao S, Loftus RW. Epidemiology of Enterococcus , Staphylococcus aureus , Klebsiella , Acinetobacter , Pseudomonas , and Enterobacter Species Transmission in the Pediatric Anesthesia Work Area Environment With and Without Practitioner Use of a Personalized Body-Worn Alcohol Dispenser. Anesth Analg. 2024 Jan 1;138(1):152-160. doi: 10.1213/ANE.0000000000006326. Epub 2023 Dec 14.

  PMID: 36623234 DERIVED

MeSH Terms

Conditions

Cross Infection

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Patrick Fernandez, MD

  University of Colorado Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two study arms to include: 1. Standard hand washing by anesthesia provider 2. Protocolized hand washing by anesthesia provider

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 20, 2019
• Study Start: December 17, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)