Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000932662
Ethics application status
Approved
Date submitted
3/08/2023
Date registered
29/08/2023
Date last updated
29/08/2023
Date data sharing statement initially provided
29/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Infection Control and Prevention with Non-Invasive Ventilation Equipment
Scientific title
Infection Control and Prevention with Non-Invasive Ventilation Equipment used with bronchiectasis, Chronic obstructive pulmonary disease, neuromuscular disorders and obesity related chronic respiratory failure: A pilot study
Secondary ID [1] 310290 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 respiratory failure requiring non-invasive ventilation 330990 0
Sleep disordered breathing treated with continuous positive airway pressure (CPAP) 330991 0
Suppurative lung disease 330992 0
Condition category
Condition code
Respiratory 327804 327804 0 0
Chronic obstructive pulmonary disease
Respiratory 327890 327890 0 0
Other respiratory disorders / diseases
Infection 327891 327891 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational study of whether pathogenic bacteria can be found on Non-invasive ventilation (NIV) machines that are used by people with and without respiratory colonisation in their lungs with bacteria. Non-invasive ventilation (NIV) machines used by patients for a minimum of 40 hours will be assessed for live cultures via swab or air sample collection onto agar and a correlate 16s RNA sample will be obtained. The aim of this study is to consider the potential for these machines to harbour pathogens when they are transferred from one person to the next. The data collected from the participant includes respiratory cultures, therapy settings, time on that device, frequency of sinus and respiratory infections and gender. No intervention is done to the participant. The researcher will access their NIV machine for a once-off period for about 6 hours to take cultures in 'as is' and then cleaned status to simulate a loan pool changeover process. The device is then returned to the participant.
NIV machines are small portable devices which help manage type 2 respiratory failure by augmenting tidal volume or number of breaths per minute into a face or nasal mask. The machines assessed in this study are both long term equipment privately owned or accessed through EnableNSW or NDIS on behalf of specific patients AND machines that are owned by Royal Prince Alfred Hospital which are streamed into in hospital use and medium-term loans for home use.
Intervention code [1] 326673 0
Not applicable
Comparator / control treatment
There is no control treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335653 0
Any growth of microbes from air sample cultures taken from the machine.
Timepoint [1] 335653 0
Samples are taken before and after the machines are cleaned.
Secondary outcome [1] 425099 0
Change in air sample microbiology post cleaning taken using andersen cascade impacter and grown onto agar
Timepoint [1] 425099 0
Air samples taken pre and post cleaning of devices
Secondary outcome [2] 425100 0
Any microbiology of concern (eg pseudamonas, legionella, aspergillus) detected from air samples collected into an Andersen cascade impactor grown on agar.
Timepoint [2] 425100 0
Air samples taken pre and post cleaning of devices
Secondary outcome [3] 425101 0
NIV machine usage as determined from NIV machine logs
Timepoint [3] 425101 0
Data download prior to microbial assessment of the device.
Secondary outcome [4] 425394 0
Change in surface sample microbiology post cleaning taken using swabs and grown onto agar
Timepoint [4] 425394 0
Samples taken before and after cleaning of NIV machine

Eligibility
Key inclusion criteria
Subjects will be recruited from either the existing home NIV database or hospital-based ventilation undertaken by the Respiratory Support Service at Royal Prince Alfred Hospital. Patients aged 18 years or older will be eligible for inclusion if they have: a physician diagnosis of CF, non-CF bronchiectasis, COPD, obesity associated chronic respiratory failure or NMD; a history of sleep hypoventilation and/or daytime hypercapnia (arterial carbon dioxide partial pressure [PaCO2]>45 mmHg); been prescribed NIV or CPAP and are using a device with an integrated humidifier (whether humidification is used or not). Usage requirements for inclusion of home based ventilation participants will be a minimum of 4 hours per might over the past four weeks, and for acute patients, at least 12 blower hours with the last use of therapy within the previous 24 hrs on the device to be tested. Participants within the Sydney metropolitan area will be offered a home visit appointment for data collection.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
major psychiatric disorders non-compliance with therapy, unable to read and understand English, inability to understand or comply with the study requirements, or inability to give informed consent.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
This is a pilot study of approximately 40 participants from 4 groups: bronchiectasis (both cystic fibrosis and non-CF bronchiectasis); COPD; neuromuscular disorders; obesity related chronic respiratory failure. We plan to recruit approximately 10 participants from each of these groups. The number of participants to be recruited in this study is based on referrals to the Respiratory Support Service at Royal Prince Alfred Hospital. Results from tests performed before and after standard cleaning of NIV and humidifier devices will be compared between 4 groups; CF and non-CF bronchiectasis, COPD, obesity associated chronic respiratory failure and neuromuscular disorders. Continuous variables will be reported as mean and standard deviation, and binary variables as frequency and percentages. Comparisons between pre and post cleaning results will be performed using one-way analysis of variance. For data without a normal distribution, Kruskal-Wallis one-way analysis of variance will be performed.
Subgroup analyses of domiciliary and acute ventilation cohorts will also be undertaken.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/09/2023
Actual
Date of last participant enrolment
Anticipated
30/10/2023
Actual
Date of last data collection
Anticipated
20/11/2023
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25324 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 41028 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 314501 0
Government body
Name [1] 314501 0
Sustainable Futures innovation grant
Country [1] 314501 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
50 Missenden Road Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 316447 0
None
Name [1] 316447 0
Address [1] 316447 0
Country [1] 316447 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313547 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 313547 0
Level 11, Royal Prince Alfred Hospital 50 Missenden Road Camperdown NSW 2050
Ethics committee country [1] 313547 0
Australia
Date submitted for ethics approval [1] 313547 0
20/01/2019
Approval date [1] 313547 0
11/05/2023
Ethics approval number [1] 313547 0
.X19-0023 &2019/ETH00115

Summary
Brief summary
This research study is investigating the effectiveness of current cleaning and disinfection procedures used for home non-invasive ventilation (NIV) or continuous positive airway pressure (CPAP) devices. Small organisms (microbes) such as bacteria or fungus can potentially be present on this equipment. The use of routine disinfection processes should remove these organisms. However, there has been limited investigation into whether NIV devices can become contaminated and how effective current cleaning processes are.

The objective is to investigate whether microbes, similar to what is in your sputum (lung mucous), are present on or inside the NIV or CPAP device prior to and after cleaning.

Most people who use NIV or CPAP at home require the use of a loan pool device in order to trial therapy and/or qualify for government funded equipment. These devices are always cleaned and disinfected by staff between patients. This process includes cleaning all accessible surfaces with special medical grade wipes and changing the filter. For this study, swabs of your NIV or CPAP machine and an air sample are going to be taken before and after the machine is cleaned using our normal cleaning process to test if the cleaning process removes any microbes that happen to be present on or in the device after you have used it.
The most important outcome of this study is comparing the number of microbes before and after we clean the device to look at how well the cleaning processes work. Microbes are everywhere in the world and inside your body and are a normal part of our environment. We are not trying to show that your machine is more or less “dirty”. We aim to show that cleaning processes work effectively by demonstrating that less microbes exist after cleaning. We are particularly interested if any microbes which might harm people with lung problems might be present on the devices, or in the air flow after they are cleaned. We do not want you to take any additional steps to “disinfect’ your machine prior to our assessment because we need some normal environmental microbes to be present for this investigation to be useful.
Trial website
Trial related presentations / publications
Public notes
The large time period between the ethics submitted and approves are due to the COVID-19 pandemic delaying the start of this project. This delay and development in the literature base and logistical change required rewriting of parts of the protocol and resubmission of amendments to the ethics office.
A possible the viral recovery from CPAP/NIV arm of the project may be conducted using overlapping methodology IF equipment is made available. For this arm people being treated in hospital with CPAP/NIV with a concurrent COVID-19 infection with positive PCR and CT values of less than 35 will be considered with a recruitment target of 5-10 cases.

Contacts
Principal investigator
Name 128502 0
Dr Amanda Piper
Address 128502 0
Respiratory Support Service, Level 11, Royal Prince Alfred Hospital, 50 Missenden Road Camperdown NSW 2050
Country 128502 0
Australia
Phone 128502 0
+61 295158708
Fax 128502 0
Email 128502 0
amanda.piper@health.nsw.gov.au
Contact person for public queries
Name 128503 0
Ms Olivia McGuiness
Address 128503 0
Respiratory Support Service, Level 11, Royal Prince Alfred Hospital, 50 Missenden Road Camperdown NSW 2050
Country 128503 0
Australia
Phone 128503 0
+61 295158708
Fax 128503 0
Email 128503 0
olivia.mcguiness@health.nsw.gov.au
Contact person for scientific queries
Name 128504 0
Ms Olivia McGuiness
Address 128504 0
Respiratory Support Service, Level 11, Royal Prince Alfred Hospital, 50 Missenden Road Camperdown NSW 2050
Country 128504 0
Australia
Phone 128504 0
+61 295158708
Fax 128504 0
Email 128504 0
olivia.mcguiness@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.