RecruitingACTRN12623000932662

Infection Control and Prevention with Non-Invasive Ventilation Equipment

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


Sponsor

Royal Prince Alfred Hospital

Enrollment

20 participants

Start Date

Jan 19, 2024

Study Type

Observational

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Many people with serious lung conditions — such as COPD, cystic fibrosis, or neuromuscular disease — use ventilation machines at home or in hospital to help them breathe. These devices, called NIV (non-invasive ventilation) or CPAP machines, are cleaned and disinfected between patients when loaned out. However, very little research has looked at how well current cleaning methods actually remove bacteria, fungi, and other microbes that can build up on these machines. This study will take swabs and air samples from NIV and CPAP devices before and after the standard cleaning process used at Royal Prince Alfred Hospital. The goal is to compare how many microbes are present before and after cleaning, and to check whether any potentially harmful microbes remain. Importantly, the study is not trying to suggest that any individual patient's machine is unsafe — it simply wants to validate that the cleaning process works. You may be eligible if you are 18 or older, have a physician diagnosis of a relevant lung condition (such as CF, COPD, or a neuromuscular disorder), have been prescribed NIV or CPAP, and use a device with an integrated humidifier. Home-based users must use the device at least 4 hours per night. People with major psychiatric disorders or who are unable to read and understand English are not eligible. The study is based at Royal Prince Alfred Hospital.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 w

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.


Locations(1)

Royal Prince Alfred Hospital - Camperdown

NSW, Australia

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ACTRN12623000932662


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