Not yet recruitingNAINTERVENTIONAL

Effects of Vibrating Mesh Nebulisation in Patients on Long-term Tracheostomy Ventilation: a Pilot Randomised Crossover Trial

This research is for people who use a tracheostomy tube and a breathing machine long-term. Many people in this situation struggle with mucus build-up, which can make breathing difficult and increase the risk of infections. The study aims to compare two different devices that deliver medicines as a fine mist (nebulisation) to the lungs: a vibrating mesh nebuliser and a jet nebuliser. Researchers want to see if the vibrating mesh nebuliser, which is a newer type, is better at helping patients clear mucus, improve their breathing, and feel less breathless. Both types of nebulisers are currently used in hospitals. This pilot study will involve a small group of patients to understand the effects of each device on breathing, heart function, and mucus levels.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Enrolment target

Start

01 Mar 2025

Estimated completion

01 May 2026

Long-term Tracheostomy Ventilated Patients

What is this study about?

This study focuses on people who need long-term breathing support through a tracheostomy tube connected to a ventilator. Often, these patients have difficulty clearing mucus from their airways, which can lead to uncomfortable breathing, blockages, and serious lung infections. This mucus build-up can delay recovery and affect their quality of life.

To help with mucus and breathing, doctors often use treatments like suctioning of the airways, medicines to thin mucus, and devices that deliver medication directly into the lungs as a fine mist (nebulisers). Patients might receive medicines like 'hypertonic saline' to help clear mucus, or 'salbutamol' to open up their airways, especially if they easily get breathing difficulties (bronchospasm).

There are different types of devices that create this fine mist. A newer type, called a vibrating mesh nebuliser, is being used more often because it's quieter and might deliver more medicine to the lungs. However, we don't yet know if it's truly better than the more traditional 'jet nebuliser' for helping patients with breathing and clearing mucus. Both types are currently used in routine care. This study will involve a small group of patients to compare the two types of nebulisers, looking at their effects on breathing patterns, heart health, mucus levels, and how breathless patients feel.

Key takeaways

Compares two types of nebulisers for people with long-term tracheostomy breathing support.
Aims to find out which nebuliser is better for breathing, clearing mucus, and reducing breathlessness.
Uses standard, prescribed medicines (hypertonic saline and salbutamol).
Participation involves monitoring at your bedside with minimal disruption.
Results could help improve future care for patients on long-term ventilation.
Participation is voluntary and will not affect your usual medical care.

Who may be eligible?

This study is looking for people who are currently receiving long-term breathing support through a tracheostomy tube as an inpatient at the Lane Fox Respiratory Service at Guy's and St Thomas' NHS Foundation Trust. You must be between 18 and 80 years old and need the breathing machine for at least 6 hours a day and for at least 21 days already.

You should also be regularly using saline or hypertonic saline in your nebuliser, and be able to have your airways suctioned to clear mucus. It's important that you can communicate how you are feeling to the research team and are able to agree to take part in the study yourself. You should also be in a stable condition, meaning your breathing support hasn't changed in the last two days.

Certain conditions would prevent you from taking part. This includes severe problems with other major organs like your heart or kidneys, severe lung problems that need urgent treatment (such as a recent lung infection called ventilator-associated pneumonia, a collapsed lung, or a blood clot in the lung), significant memory or thinking problems, or if you've previously had a bad reaction to inhaled hypertonic 3% saline or salbutamol.

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.

Are you an inpatient at the Lane Fox Respiratory Service at Guy's and St Thomas'?
Do you currently use a tracheostomy tube and breathing machine long-term (at least 6 hours/day for 21+ days)?
Are you between 18 and 80 years old?
Do you already use saline or hypertonic saline in your nebuliser?
Are you generally stable and able to communicate how you feel?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be in the study for a short period while you are an inpatient. You'll receive nebulised medicines (hypertonic saline and salbutamol) using two different types of nebuliser over two separate treatment periods. On some days, you'll use the vibrating mesh nebuliser, and on other days, the jet nebuliser. This setup allows researchers to compare the effects of each device directly.

During these periods, the research team will monitor various aspects of your health. This includes checking your breathing patterns, heart rate, and how much oxygen is in your blood. They will also assess how much mucus you produce and how breathless you feel, and they'll ask you about your symptoms. There are no extra hospital visits involved, as all assessments will be done at your bedside in the hospital. The total duration of your active involvement in the study will be relatively short, likely a few days, depending on the schedule of treatments and assessments. You will not be asked to take any new medications, only to receive your usual nebulised medicines via the different devices.

Potential risks and benefits

Taking part in this study could help us learn more about the best way to deliver nebulised medicines for people with long-term tracheostomy ventilation, potentially improving care for many in the future. As both types of nebulisers are already used in routine care, serious risks are not expected. However, as with any medical procedure, there's always a small chance of unexpected side effects. You might experience some mild discomfort during assessments or if your medication causes a temporary change in breathing, although this is carefully monitored. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Lane Fox Unit, St Thomas' Hospital
Verified postcode
London, United Kingdom

Common questions

What is a tracheostomy tube?

A tracheostomy tube is a small tube placed into your windpipe (trachea) through a small opening in your neck to help you breathe, usually when you need long-term support from a breathing machine.

What is a nebuliser?

A nebuliser is a device that turns liquid medicine into a fine mist, which you can breathe directly into your lungs through a mask or mouthpiece, or in this case, through your tracheostomy tube.

What is the difference between a vibrating mesh and a jet nebuliser?

Both types deliver medicine as a mist. A jet nebuliser uses compressed air, while a vibrating mesh nebuliser uses a mesh with tiny holes that vibrates to create the mist. Researchers are comparing which works better.

Will I have to take new medicines?

No, you will receive two medicines, hypertonic saline and salbutamol, that are already part of your usual care. The study is only comparing how these medicines are delivered by different devices.

Does taking part affect my regular care?

No, your regular medical care will continue as normal. You can also withdraw from the study at any time without it affecting your treatment.

How to find out more

Eui-Sik Suh, MBBS MChem(Oxon) PhD FRCP

euisik.suh@gstt.nhs.uk +44207 188 7727 Official trial record

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