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Trial registered on ANZCTR


Registration number
ACTRN12614000034639
Ethics application status
Approved
Date submitted
17/12/2013
Date registered
10/01/2014
Date last updated
7/10/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
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?
Scientific title
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?
Secondary ID [1] 283566 0
Nil
Universal Trial Number (UTN)
U1111-1150-1636
Trial acronym
HPVICU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intensive Care Unit room cleaning impact on transmission of organisms.
 290471 0
Condition category
Condition code
Public Health 290863 290863 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 288260 0
Prevention
Comparator / control treatment
Control Arm –
Another 8 Intensive Care Unit rooms have been permanently randomised to receive traditional wet cleaning methods as the normal cleaning on discharge of patients from the Intensive Care Unit.

The control rooms are continuing to use the existing traditional wet cleaning methods involving detergents and disinfectants.


Control group
Active

Outcomes
Primary outcome [1] 290859 0
Clostridium difficile and/or Multi-Resistant Organisms (MRO's) acquisition rate (composite of all MROs) as determined by
- admission swabs screening for MRO’s only (not C.Difficile)
- discharge swabs screening for MRO’s only (not C.Difficile)
- any positive culture result (clinical specimen) for Clostridium difficile and/or MRO acquisitions (both clinically meaningful and non-clinically meaningful acquisitions) from 48 hours post admission up to 48 hours post discharge from ICU.

To record an acquisition for a specific MRO, there must be a negative result for that organism on the admission screen followed by detection in either the discharge swabs or a clinical specimen obtained up to 48hrs following ICU discharge.

Any positive culture result from the first 48 hours of an admission would be excluded on basis that the organism is unlikely to have come from Intensive Care. Similarly upon discharge, the next 48 hours would be considered as having come from Intensive Care.
Timepoint [1] 290859 0
The primary timepoint will be at time of admission to Intensive Care Unit (ICU) and at time of discharge, as well as 48 hours post admission and at 48 hours post discharge.
Secondary outcome [1] 305478 0
Any clinical infections, as evidenced by commencement of antibiotics within ICU (excluding cephazolin which is used as surgical and post trauma prophylaxis) from 48 hours post admission up to 48 hours post discharge from Intensive Care Unit with objective evidence (positive culture result)
Timepoint [1] 305478 0
The secondary timepoint will be at time of admission to Intensive Care Unit (ICU) and at time of discharge, as well as 48 hours post admission and at 48 hours post discharge.
Secondary outcome [2] 305479 0
Any clinical infections, as evidenced by commencement of antibiotics within ICU (excluding cephazolin which is used as surgical and post trauma prophylaxis) from 48 hours post admission up to 48 hours post discharge from ICU without objective evidence (i.e. started without positive culture results).
Timepoint [2] 305479 0
The secondary timepoint will be at time of admission to Intensive Care Unit (ICU) and at time of discharge, as well as 48 hours post admission and at 48 hours post discharge.
Secondary outcome [3] 305480 0
ICU associated blood stream infections, as evidenced by significant positive blood cultures (single set coagulase negative staphylococci are defined as contaminant isolates) from 48 hours post admission up to 48 hours post discharge from ICU.
Timepoint [3] 305480 0
The secondary timepoint will be at time of admission to Intensive Care Unit (ICU) and at time of discharge, as well as 48 hours post admission and at 48 hours post discharge.
Secondary outcome [4] 305481 0
Room cleaning time as determined from manual collection of actual time taken to clean each room. This will be from a form which will be completed by the cleaners for each room cleaned.
Timepoint [4] 305481 0
When room is available for use for the next patient.

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a single centre, cluster randomised controlled trial.

The rooms were randomly assigned within each group of four rooms to either standard cleaning or the intervention of Hydrogen Peroxide cleaning. This assignment was completed prior to the trial starting and will be maintained throughout the trial.

The John Hunter Hospital Intensive Care Unit has a bed occupancy of over 90% and hence patients are allocated to a room based on first available and nursing considerations which will continue unchanged from current practices.

The patients are blinded. The laboratory staff analysing the cultures sent to the laboratory are also blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer Generated.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Note that it is a Cluster Randomised Controlled Trial.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Initial analysis will seek to confirm that cluster randomisation has worked and that patient characteristics in the HPV rooms are similar to those in the standard rooms on key characteristics, in particular: age, gender, APACHE score, significant comorbidities and ICU length of stay.

Analyses of the primary and secondary outcomes will be by Chi-squared test since each of these is dichotomous (acquisition of MRO during the ICU stay, clinical infection as judged by starting an antibiotic. These tests will incorporate the design effect created by the cluster design.

An interim analysis will be made at 4 months to confirm the actual sample size required.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1848 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment postcode(s) [1] 7632 0
2305 - New Lambton Heights

Funding & Sponsors
Funding source category [1] 288249 0
Charities/Societies/Foundations
Name [1] 288249 0
John Hunter Charitable Trust
Country [1] 288249 0
Australia
Funding source category [2] 288250 0
Hospital
Name [2] 288250 0
John Hunter Hospital
Country [2] 288250 0
Australia
Primary sponsor type
Individual
Name
Dr Bruce Seidel
Address
John Hunter Hospital
Lookout Road
New Lambton Heights
New South Wales, 2305
Australia
Country
Australia
Secondary sponsor category [1] 286965 0
Individual
Name [1] 286965 0
Dr Ken Havill
Address [1] 286965 0
John Hunter Hospital
Lookout Road
New Lambton Heights
New South Wales, 2305
Australia
Country [1] 286965 0
Australia
Secondary sponsor category [2] 286966 0
Individual
Name [2] 286966 0
Associate Professor John Ferguson
Address [2] 286966 0
John Hunter Hospital
Lookout Road
New Lambton Heights
New South Wales, 2305
Australia
Country [2] 286966 0
Australia
Secondary sponsor category [3] 286967 0
Individual
Name [3] 286967 0
Professor John Attia
Address [3] 286967 0
John Hunter Hospital
Lookout Road
New Lambton Heights
New South Wales, 2305
Australia
Country [3] 286967 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290153 0
Hunter New England Research Ethics and Governance Unit
Ethics committee address [1] 290153 0
Locked Bag No 1
New Lambton NSW 2305
Ethics committee country [1] 290153 0
Australia
Date submitted for ethics approval [1] 290153 0
11/10/2012
Approval date [1] 290153 0
11/10/2012
Ethics approval number [1] 290153 0
12/10/17/5.06

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44202 0
Dr Bruce Seidel
Address 44202 0
John Hunter Hospital
Intensive Care Unit
Lookout Road
New Lambton Heights
New South Wales, 2305
Country 44202 0
Australia
Phone 44202 0
+61249213000
Fax 44202 0
Email 44202 0
[email protected]
Contact person for public queries
Name 44203 0
Bruce Seidel
Address 44203 0
John Hunter Hospital
Intensive Care Unit
Lookout Road
New Lambton Heights
New South Wales, 2305
Country 44203 0
Australia
Phone 44203 0
+61249213000
Fax 44203 0
Email 44203 0
[email protected]
Contact person for scientific queries
Name 44204 0
Bruce Seidel
Address 44204 0
John Hunter Hospital
Intensive Care Unit
Lookout Road
New Lambton Heights
New South Wales, 2305
Country 44204 0
Australia
Phone 44204 0
+61249213000
Fax 44204 0
Email 44204 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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