RecruitingOBSERVATIONAL

Respiratory Muscle Structure and Function in Mechanically Ventilated Patients and Long-term Outcomes

The RESPIRE study investigates how the muscles we use for breathing, like the diaphragm and tummy muscles, are affected when someone is on a breathing machine (mechanical ventilation) in hospital. Sometimes, using a breathing machine can make these muscles weaker, making it harder for patients to breathe on their own again. This study wants to understand this process better and see how it impacts a patient's overall health and quality of life after leaving the hospital. Researchers will also look at how information from the breathing machine itself might help predict when a patient is ready to come off it. The goal is to find ways to help patients recover faster and live well after such a serious illness.

At a glance

Status

Recruiting

Sponsor

University Health Network, Toronto

Enrolment target

230

Start

27 Apr 2023

Estimated completion

30 Jun 2026

Mechanical Ventilation Complication Diaphragm Injury Lung Injury Respiratory Insufficiency Abdominal Muscle Strained

What is this study about?

When you're very ill, sometimes your body needs help to breathe, and doctors use a machine called a ventilator. This machine gently pushes air into your lungs. While it's doing this life-saving work, your breathing muscles, like your main breathing muscle called the diaphragm and muscles in your tummy, get a rest. However, this rest can sometimes lead to these muscles becoming weaker, much like how an arm or leg muscle might get weaker if you don't use it for a while.

This study, called RESPIRE, wants to understand exactly what happens to these breathing muscles when someone is on a ventilator. We know that if the diaphragm gets too weak, it can make it harder for patients to stop using the ventilator and breathe on their own. We're also looking at the tummy muscles in the same way. By understanding how these muscles change and work together, we hope to find out why some patients take longer to recover and how this affects their health and daily life long after they leave the hospital.

We'll also be looking at new ways to use information from the breathing machine itself. This might help doctors better predict when a patient is strong enough to breathe without the machine. The ultimate aim is to improve care for patients on ventilators, help them recover their strength, and get back to their normal lives as quickly and effectively as possible.

Key takeaways

The study looks at how breathing muscles change when a patient is on a ventilator.
It aims to understand why some patients take longer to breathe on their own again.
Information gathered could improve recovery for future patients.
Measurements include ultrasound scans and analysis of body samples.
No new medications are given as part of the study.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for adults aged 18 or over. You might be able to take part if you are currently in intensive care (ICU) and have recently started using a breathing machine to help you breathe. This also includes people who are using a non-invasive breathing machine (like a mask) or even those in ICU who only need a little bit of oxygen or no breathing support at all. We want to compare what happens in different situations.

However, there are some reasons why you might not be able to join. For example, if doctors expect you to come off the breathing machine very soon, or if you've already had a special test to see if you can breathe on your own. You also can't take part if you have a known nerve or muscle disease, or if you've needed a breathing machine for a long time before your current hospital stay.

We also can't include people who have already been in this study before, or if it would be difficult for the researchers to keep in touch with you after you leave the hospital, for example, if you live outside the UK or don't have a fixed address. These rules help make sure the study collects the right information to answer its questions.

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 18 years old or older?
Are you currently in the intensive care unit (ICU)?
Have you started using a breathing machine (ventilator) or other breathing support within the last 36 hours?
Do you have a fixed address in the UK?
Do you not have a pre-existing nerve or muscle condition?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the research team will regularly check your breathing muscles. This will involve using an ultrasound scan, which is a bit like the scans used during pregnancy to see inside the body, but it will be focused on your diaphragm and tummy muscles. They will also take some measurements of your breathing and collect some samples, like blood or other bodily fluids, to look at specific markers related to muscle health. These checks will happen while you are in the intensive care unit. After you leave the hospital, the team will ask you to complete questionnaires about your health and quality of life to see how you are recovering long-term. There are no new medications given as part of this study. The total duration of your participation, including follow-up, will depend on your hospital stay and recovery.

Potential risks and benefits

Taking part in this study might not directly benefit you, but the information we gather could help improve care for future patients who need breathing machines. All the procedures are generally considered safe; for example, ultrasound scans are non-invasive and painless. There are no known risks from the measurements taken. You would be given extra attention from the research team, providing comfort. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Toronto General Hospital
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is mechanical ventilation?

It's a medical treatment where a machine helps you breathe, usually when your lungs aren't working well enough on their own due to serious illness.

What are breathing muscles?

These are the muscles, like your diaphragm (the main one under your lungs) and some tummy muscles, that make your chest expand and contract to help you breathe in and out.

Will this study give me new medicine?

No, this study is only about observing your breathing muscles and taking measurements. You won't receive any new medications specific to the study.

What is an ultrasound scan?

It's a safe and painless test that uses sound waves to create images of the inside of your body, like your muscles, so doctors can see them.

Can I leave the study if I change my mind?

Yes, you can choose to stop participating in the study at any time, and it won't affect the care you receive from your doctors.

How to find out more

Rongyu (Cindy) Jin

rongyu.jin@uhn.ca 4163404800 Official trial record

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