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RecruitingNAINTERVENTIONAL

Optimisation of Mechanical Insufflation:Exsufflation

This study aims to improve treatments for people with muscle conditions that affect their breathing. Many people with conditions like muscular dystrophy have weak breathing muscles, making it hard to cough up mucus. This can lead to infections and serious health problems. We use a special machine called a mechanical insufflation-exsufflation (MIE) device to help clear airways. While these devices are helpful, we're not sure about the best way to use them. This study will explore different settings on these machines to see which ones clear mucus most effectively and comfortably, without causing any unwanted side effects, like harming the lungs or heart.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Enrolment target
30
Start
19 Dec 2019
Estimated completion
28 Feb 2027

What is this study about?

For people living with conditions that make their muscles weaker, like some types of muscular dystrophy, breathing can become a challenge. This often means the muscles you use to cough aren't as strong as they should be. When you can't cough effectively, mucus can build up in your airways, leading to infections and making it harder to breathe. To help with this, doctors sometimes recommend a special device called a mechanical insufflation-exsufflation (MIE) machine.

This machine works by gently pushing air into your lungs (insufflation) and then quickly pulling it out (exsufflation), to mimic a strong cough and help clear out mucus. While we know these devices are helpful, we're still learning about the very best way to use them. For example, using too much pressure might cause problems, even though some studies hint that higher pressures could be useful. We need to find the right balance so that these machines are as effective as possible without any risks.

This study wants to figure out the best settings for these MIE machines. We'll be looking at things like how much air we can gently push in to help widen your lungs, what the smallest pressure difference is needed to help clear mucus, whether these settings might accidentally cause your throat to close up (which would not be helpful for clearing mucus), and what patients themselves think about using these machines, as their comfort and ease of use are really important.

Key takeaways

  • Study explores best MIE device settings for muscle-weakening conditions.
  • Aims to improve mucus clearance and breathing comfort.
  • Involves two visits to a specialist unit, each lasting about four hours.
  • Does not involve new medications.
  • Focuses on patient comfort and safety during device adjustments.

Who may be eligible?

To join this study, you generally need to have a muscle-weakening condition that isn't getting worse quickly, or if it is changing, it's doing so slowly and steadily. You'll also need to have some weakness in your breathing muscles, or issues with mucus in your lungs or a history of chest infections that make you cough a lot.

There are also some reasons why you wouldn't be able to join. For example, if your condition is getting worse very quickly (like some types of motor neuron disease), or if you are pregnant. You must also be 18 years old or older. If you've recently had changes to your breathing machine settings or have other major health issues that would make it hard to follow the study's plan, you wouldn't be able to participate. Your doctor will carefully check if this study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Do you have a muscle-weakening condition that is not getting worse quickly?
  2. Are you 18 years old or older?
  3. Do you have some weakness in your breathing muscles or issues with mucus/cough?
  4. Are you able to visit the Lane Fox Respiratory Unit twice?
  5. Are you not currently pregnant?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would need to visit the Lane Fox Respiratory Unit twice. Each visit is expected to last about four hours. During these visits, we would test different settings on the mechanical insufflation-exsufflation (MIE) device to see how well they help clear your airways and how comfortable they are for you. You won't be given any new medications as part of this study. The total duration of your involvement will be these two visits.

Potential risks and benefits

A potential benefit of joining this study is that we might find better ways to use these breathing support machines, which could improve how well they clear mucus and make breathing easier for you and others in the future. We will carefully monitor you to make sure you are comfortable and safe during all tests. There's a small risk that trying different pressure settings might cause temporary discomfort or, in rare cases, affect lung or heart function, but we will use very careful monitoring to prevent this. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Guys & St. Thomas' NHS Foundation Trust
    Verified postcode
    London, United Kingdom· Recruiting

Common questions

What is a mechanical insufflation-exsufflation (MIE) device?

It's a machine that helps people with weak breathing muscles to cough up mucus by gently pushing air in and then quickly pulling it out of the lungs.

Why is this study important?

It's important because we want to find the safest and most effective way to use these devices to help people with muscle कमजोरी conditions breathe better and stay healthier.

Will I have to take any new medicines?

No, this study focuses on adjusting the settings of the MIE device, not on new medicines.

How long will each visit take?

Each of your two visits to the hospital will take about four hours.

What if I feel uncomfortable during the study?

Your comfort and safety are our top priority. You can stop the study at any time if you feel uncomfortable, and it won't affect your medical care.

How to find out more

Patrick Murphy, PhD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Optimisation of Mechanical Insufflation:Exsufflation…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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