Not Yet RecruitingPhase 4ACTRN12614000034639

Does disinfection of Intensive Care Unit rooms with Hydrogen Peroxide Vapour, in adults, compared to standard disinfection practices, is equivalent to, or reduce the transmission to patients of Clostridium difficile and multi-resistant organisms?


Sponsor

Dr Bruce Seidel

Enrollment

800 participants

Start Date

Nov 1, 2014

Study Type

Interventional

Conditions

Summary

The transmission and acquisition of health care associated microorganisms by hospitalised patients is associated with serious morbidity. Critically ill patients are particularly susceptible to serious infections with these organisms due to the nature of their illness and the numerous vascular and intra-cavity devices they have. It is known that persistence of these organisms within the healthcare environment is a major source of these transmissions. Environmental cleaning is important in the control of these organisms and traditionally relies on wet cleaning methods of the patient environment with detergents and disinfectants. This process of cleaning is time consuming, requiring significant resources and personnel. In addition, much of the environment is not easily amenable to these cleaning methods (e.g under surfaces, monitoring devices). Increasing bed occupancy and bed turnover creates added pressure to the effectiveness of these traditional cleaning methods. Hydrogen peroxide vapour (HPV) is an attractive alternative to these traditional cleaning strategies. This is due to being less personnel dependent, the vapour will effectively reach more difficult areas, simplifies complex cleaning process for numerous types of surfaces and recent evidence suggests that it is more effective in eliminating environmental organisms than traditional disinfection treatments. This study aims at assessing the effectiveness and practicality of using HPV compared to traditional cleaning methods in the routine ICU patient discharge cleaning process. Specifically we are looking at the control of the acquisition of hospital acquired organisms by patients in a busy general intensive care unit. Null Hypothesis: “ That Hydrogen Peroxide Vapour is no better than standard double cleaning (viraclean and detergent, no bleach) procedures in regards to acquisition of hospital acquired Clostridium difficile and multiresistant organisms during the course of an ICU admission. “ The Multi Resistant Organism (MROs) acquisitions to be measured include: - Multi Resistant Gram Negative bacteria (MRGN), - Methicillin Resistant Staphylococcus aureus (MRSA), - Vancomycin Resistant enterococci (VRE) and Clostridium Difficile cultures will only be collected if they are clinically indicated. Clostridium Difficile will not be included on routine admission and discharge swabs to Intensive Care. There will be a planned interim analysis at 4 months to re-calculate the sample size required.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

  • Any adult patient admitted into Intensive Care Unit zone A or B of duration greater than 48 hours. Each zone consists of 8 single beds.

Exclusion Criteria8

  • Any patient of age < 18 years
  • Specific MRO’s will be excluded for those patients that have that specific MRO identified on:
  • a) initial ICU admission screening swabs
  • b) or any known prior specific positive culture of an MRO as recorded in the hospital Patient Information Management System and/or Microbiology database
  • Any readmission to ICU
  • Only those patients admitted for the first time to ICU during this hospital admission will be included, subsequent admissions will be excluded
  • An admission of less than 48 hours duration
  • Discharge swabs are still collected even if patients should die during their admission.

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Interventions

Intervention Arm – 8 Intensive Care Unit rooms have been permanently randomised to receive Hydrogen Peroxide Vapour (HPV) disinfection cleaning as the normal cleaning on discharge of patients from th

Intervention Arm – 8 Intensive Care Unit rooms have been permanently randomised to receive Hydrogen Peroxide Vapour (HPV) disinfection cleaning as the normal cleaning on discharge of patients from the Intensive Care Unit. The process involves using the existing hospital cleaning staff (sometimes nurses). The cleaning staff remove all visibly soilded material and any dust. The mattress of the bed is propped up on the bed frame. Any equipment is to be left in the room (including electical equipment). The consumables are left exposed in the room. The Hydrogren Peroxide vapouriser is placed inside the room and the room is then sealed. A control panel linked to the machine is located outside the room. The Vapouriser performs a cleaning cycle. The room is then checked and consumables, mattress and equipment replaced back into the correct position. The vapouriser cleaning cycle will take approximately 90 minutes, with overall room cleaning time expected to be similar to the traditional cleaning mthods. It is expected that the intervention period will be approximately 9 months. We will have a more accurate time frame after the planned interim analysis at 4 months to confirm the sample size required.


Locations(1)

John Hunter Hospital Royal Newcastle Centre - New Lambton

NSW, Australia

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ACTRN12614000034639