RecruitingOBSERVATIONAL

Inspiratory Work of Breathing Before and After Extubation

This study aims to understand how different ways of taking patients off breathing machines impact their breathing effort and lung health. Critically ill patients, especially those who have had lung transplants, sometimes need a breathing machine. When they're well enough, doctors try to remove this machine. This study will use special equipment, like a new imaging tool and a small tube in the food pipe, to measure how their lungs work and how hard they have to breathe during this process. The goal is to find the safest and most effective way to help patients breathe on their own again, preventing problems like lung damage or pneumonia that can happen if the machine is removed too early or too late.

At a glance

Status

Recruiting

Sponsor

University Health Network, Toronto

Enrolment target

Start

01 Sep 2020

Estimated completion

01 Dec 2026

Lung Transplant; Complications Ventilator-Induced Lung Injury Ventilator Associated Pneumonia

What is this study about?

When people are very poorly, they sometimes need help to breathe. This usually means a tube is put down their windpipe, and a machine (called a ventilator) breathes for them. Once they start to get better and the original problem is sorted, doctors try to gently take them off the breathing machine so they can breathe on their own again. This process is called 'extubation'. Bringing someone off a breathing machine safely is very important because if it's done too soon or too late, it can cause problems like weakening of breathing muscles or lung infections.

To figure out if a patient is ready to breathe by themselves, doctors often do a 'spontaneous breathing test'. There are different ways to do this test, and doctors are still trying to find the very best method. In this study, taking place in Toronto, patients will go through a common type of breathing test. During this test, and again after the breathing tube has been safely removed, researchers will use special tools. These include a new imaging method that helps them see how the lungs are working, and a tiny tube placed in the food pipe which helps to measure pressures inside the chest. They will also look at how much effort the patient is putting into each breath.

The main aim of this research is to get a clearer picture of how a specific breathing test affects lung function and the effort involved in breathing for lung transplant patients. By understanding this better, we hope to improve how doctors decide when and how to take patients off breathing machines, making the process smoother and safer for everyone involved.

Key takeaways

A patient will be monitored with special tools during and after coming off a breathing machine.
This study aims to find the best way to help patients breathe on their own after being on a ventilator.
Measurements will assess lung function and how hard a patient has to breathe.
The study focuses on adult lung transplant patients.
It uses new technology to better understand breathing mechanics.

Who may be eligible?

This study is looking for adult patients who are currently in the hospital, need a breathing machine, and have had a lung transplant. Both men and women can take part.

However, some people might not be able to join the study. For example, if you've recently had surgery on your upper digestive system (like your food pipe or stomach) in the last six weeks, or if you have certain bleeding conditions in your food pipe, you wouldn't be able to have the small tube placed there.

Also, if you have a condition called a bronchopleural fistula (a connection between your airway and the space around your lung), or if you have burns, skin issues, or bandages on your chest that would stop the special imaging equipment from working properly, you wouldn't be able to join. Pregnant women are also unable to take part in this study.

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 adult (18 years or older)?
Are you currently on a breathing machine?
Have you had a lung transplant?
Do you have any recent surgery on your food pipe or stomach (in the last 6 weeks)?
Do you have any skin issues or burns on your chest?
Are you pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be monitored during a standard breathing test while still on the breathing machine. During this time, researchers would use a new imaging technology on your chest and place a small, temporary tube in your food pipe to measure lung pressures and breathing effort. Once the breathing tube is safely removed, these measurements would be repeated. All these steps are part of the normal care you would receive, with the addition of these specific measurements to collect research data. The total duration of your involvement would be focused around the time you are being taken off the breathing machine.

Potential risks and benefits

Taking part could help us understand how to improve care for future patients needing breathing support, though it might not directly benefit you. The study involves measurements that are part of standard care, but also includes additional monitoring with new equipment and an esophageal catheter. There's a small risk associated with placing the small tube in the food pipe, such as minor discomfort, and the new imaging equipment is safe. You are free to decide whether to participate, and you can withdraw from the study at any time without affecting your medical care.

Locations (1)

Toronto General Hospital, University Health Network
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is a 'breathing machine'?

A breathing machine, also called a ventilator, is a medical device that helps you breathe when you are too unwell to do it fully on your own. It pushes air into your lungs.

What does 'extubation' mean?

Extubation is when the breathing tube that goes down your windpipe to the breathing machine is safely removed, allowing you to breathe by yourself again.

What is a 'spontaneous breathing test'?

This is a test doctors do to see if you are strong enough to breathe on your own before they remove the breathing tube. It’s like a trial run for your breathing muscles.

Is the new imaging tool safe?

Yes, the new imaging tool works by sending small, safe electrical signals through your chest to create pictures of your lungs, similar to how an X-ray works but without radiation.

Will taking part change my normal care?

No, your medical care will not change. This study involves adding extra measurements during your routine care to gather information for research.

How to find out more

Glauco Plens, MD

glauco.plens@uhn.ca 416-340-4800 Official trial record

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