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Can Waveform and Flow Traces From Mechanical Insuflattion:Exsufflation (MI:E) be Used to Identify Laryngeal Responses to MI:E and Thus Optimise Treatment Algorithms?

This research aims to help people with conditions like Motor Neurone Disease or Muscular Dystrophy who use a 'cough assist' machine. These machines help clear airways when muscles are weak. The study will explore if special patterns shown on the cough assist machine's screen can tell physiotherapists if a patient's voice box is reacting unusually during treatment. They will also investigate how different machine settings affect these reactions. The main goal is to create clearer guidelines for physiotherapists, helping them use the cough assist machine more effectively and safely. This could lead to better breathing support for patients.

At a glance

Status
Recruiting
Sponsor
Royal Free Hospital NHS Foundation Trust
Enrolment target
20
Start
01 Jan 2022
Estimated completion
01 Jan 2025

What is this study about?

This study is designed to help people with conditions that weaken their muscles, such as Motor Neurone Disease, Multiple Sclerosis, or Muscular Dystrophy. Sometimes, these conditions can make it hard to cough properly, which means mucus can build up in the lungs and cause breathing problems. 'Cough assist' machines are used to help clear these airways by giving a breath in and then a quick puff out.

The main idea behind this research is to see if physiotherapists can get more information from the cough assist machine itself. The machine produces little squiggly line patterns on a screen, like a heartbeat monitor. The study wants to find out if these patterns can show when a patient's voice box (larynx) is reacting in an unusual way to the cough assist treatment. This is important because sometimes the voice box can close up or respond in other ways that might make the treatment less effective or uncomfortable.

Researchers will also look at how changing the machine's settings, like the strength of the breath in and the cough out, affects a patient's voice box and overall response. Ultimately, the goal is to create clear advice and guidelines for physiotherapists. This will help them understand how to interpret the machine's signals and adjust the treatment to be as safe and helpful as possible for each patient, making breathing easier and improving quality of life.

Key takeaways

  • This study aims to improve how 'cough assist' machines are used for people with muscle-weakening conditions.
  • It investigates if machine readouts can show throat reactions during treatment.
  • The research will involve breathing tests and a small camera to look at your voice box.
  • The goal is to provide guidelines for physiotherapists to optimise treatment.
  • You must be 18 or over and have a qualifying muscle-weakening condition to participate.

Who may be eligible?

This study is looking for adults aged 18 or older who have certain muscle-weakening conditions. This includes people with Motor Neurone Disease, Multiple Sclerosis, or Muscular Dystrophy, among others.

You would not be able to join if you have a breathing condition that blocks your airways, such as severe asthma. Also, you can't take part if you have certain other medical issues, like a collapsed lung that hasn't been treated, very low blood pressure, serious bleeding when coughing, recent facial injuries, or if you're frequently being sick. You also need to be able to understand what's involved and agree to take part.

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. Are you 18 years old or older?
  2. Do you have a muscle-weakening condition like Motor Neurone Disease or Muscular Dystrophy?
  3. Are you able to understand the study and agree to take part?
  4. Do you have any existing severe breathing problems such as badly blocked airways?
  5. Have you recently had any serious bleeding when coughing or significant facial injuries?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would first have some basic breathing tests to check your lung function. These tests include spirometry, which measures how much air you can breathe in and out, and some other simple checks. Then, a tiny camera will be used to gently look at your voice box while it's resting. This camera goes into your nose and helps the researchers see how your voice box moves.

Next, a physiotherapist, who is experienced with 'cough assist' machines, will use the machine with you through a face mask. While the cough assist machine is working, the camera will still be in your nose to record exactly what your voice box is doing. The patterns shown on the cough assist machine's screen will also be recorded and compared with the camera's video. A separate device that also measures airflow will be connected to the cough assist machine to check its readings. The full duration of your participation will be explained by the study team.

Potential risks and benefits

Taking part in research always has a balance of potential benefits and risks. A potential benefit of this study is that it could lead to better, more personalised care when using a 'cough assist' machine in the future. There are no direct benefits to you from participating. Potential risks might include some minor discomfort from the breathing tests or the small camera in your nose. The 'cough assist' treatment itself will be given by an experienced physiotherapist. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Royal Free London NHS foundation Trust
    Verified postcode
    London, United Kingdom· Recruiting

Common questions

What is a 'cough assist' machine?

It's a device that helps people with weak muscles clear their airways by delivering a breath in and then a quick outward puff, like a cough.

What will the camera in my nose be used for?

It helps the researchers see how your voice box (larynx) responds when you're using the cough assist machine.

Will I have to take any new medicines?

No, this study does not involve any new medicines. It focuses on how a medical device is used.

How long will my visit to the study take?

The information doesn't specify an exact time, but the study team will provide full details about the expected duration of your participation.

Can I stop being part of the study once I've started?

Yes, you can choose to leave the study at any point without it affecting your medical care.

How to find out more

Stephanie Mansell

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 "Can Waveform and Flow Traces From Mechanical Insuflattion:Ex…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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