RecruitingOBSERVATIONAL

Diaphragm Structure and Pathobiology in Patients Being Bridged to Lung Transplant

This research study is about understanding how different types of breathing support, like mechanical ventilators or other life support machines, affect a very important breathing muscle called the diaphragm. People who are waiting for a lung transplant often need these machines, but sometimes the machines can accidentally hurt the diaphragm. Researchers want to see if specific types of breathing support lead to different amounts of damage to this muscle. They are using a special ultrasound scan to look at the diaphragm closely. By comparing these ultrasound pictures with samples of the muscle viewed under a microscope, they hope to learn the best ways to keep the diaphragm healthy and how to interpret what they see on the ultrasound images. This could help improve care for patients needing breathing support.

At a glance

Status

Recruiting

Sponsor

University Health Network, Toronto

Enrolment target

Start

01 Apr 2019

Estimated completion

30 Dec 2025

Diaphragm Injury Respiratory Failure Mechanical Ventilation Complication

What is this study about?

Imagine your diaphragm as a large, dome-shaped muscle under your lungs that does most of the work when you breathe in. For people who are very unwell and waiting for a lung transplant, breathing machines are often a lifeline. These machines, known as mechanical ventilators or other life support systems, help you breathe when your lungs are too weak to do it on their own.

However, sometimes these breathing machines can unexpectedly affect the diaphragm muscle. It's a bit like a muscle in your arm: if you don't use it at all, it can get weak, but if you overwork it, it can also get strained or injured. The problem is, when someone is on a breathing machine, it's hard to know if the diaphragm is getting too much rest, too much work, or just the right amount. If the diaphragm gets injured or stops working well, it can make it much harder for someone to breathe on their own again after treatment.

This study aims to understand exactly what happens to the diaphragm muscle when people receive different kinds of breathing support. Researchers are using a special ultrasound scan to get a close look at the diaphragm muscle, seeing how its size and how well it moves changes over time. They will also compare these ultrasound findings with tiny samples of the muscle seen under a powerful microscope to truly understand what's happening at a very detailed level. By doing this, they hope to discover which types of breathing support are gentlest on the diaphragm and how doctors can best use ultrasound to check its health, ultimately helping patients recover better.

Key takeaways

Study explores how breathing machines affect the diaphragm muscle.
Aims to find best ways to protect the diaphragm in transplant patients.
Uses ultrasound and tissue samples to understand changes.
May help improve future care for people needing breathing support.
Participants must be adults (18+) on breathing support for a lung transplant or undergoing certain surgeries.

Who may be eligible?

To be part of this study, you generally need to be an adult (18 years or older) and be receiving breathing support while waiting for a lung transplant. The study is also looking for two other groups of people as comparisons: those having a lung transplant for different reasons, and those having chest surgery who don't have long-term lung problems.

There are also some reasons why you wouldn't be able to join. For example, if you've already been diagnosed with a nerve or muscle condition that affects your movement or breathing, or if you've had extensive mechanical breathing support recently for longer than two days.

Anyone who has an unusual shape to their chest bones would also not be eligible, as this could affect the measurements taken during the study. The study includes both men and women.

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 receiving breathing support while waiting for a lung transplant?
Do you have a nerve or muscle condition?
Have you had more than 48 hours of mechanical breathing support in the last four weeks?
Do you have an unusual chest shape?

Answer every question to see your result.

What does participation involve?

The detailed explanation of what taking part involves is not provided in the original text. Typically, participation in a study like this could involve regular ultrasound scans of your diaphragm, possibly providing small tissue samples for microscopic examination (if it's already necessary for your treatment), and potentially having your breathing machine settings monitored closely by the research team. The total duration of your participation would depend on how long you need breathing support and are listed for transplant, but this information is not specified here. There's no mention of taking new medications as part of this study.

Potential risks and benefits

Potential benefits of taking part include helping doctors understand more about how breathing support affects the diaphragm, which could lead to better care for future patients. While specific individual benefits are not guaranteed, contributing to medical knowledge is valuable. Potential risks are not detailed but could include slight discomfort from ultrasound procedures or the inconvenience of extra monitoring. Any procedure involving tissue samples carries minor risks, but these are usually associated with standard medical care. Participants always have the right to withdraw from the study at any time without affecting their medical care.

Locations (1)

Toronto General Hospital
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is the diaphragm?

It's your main breathing muscle, located under your lungs. It helps you breathe in.

Why are researchers interested in my diaphragm?

Breathing machines, while life-saving, can sometimes affect this muscle. Researchers want to find the safest ways to support your breathing.

What is 'mechanical ventilation'?

It's a medical treatment where a machine helps you breathe when your lungs can't do it enough on their own.

Will I have to take new medicines for this study?

The information provided doesn't mention any new medications as part of this study.

Can I leave the study if I change my mind?

Yes, you can always decide to stop being part of the study at any time, and it won't affect your medical care.

How to find out more

Rongyu (Cindy) Jin

rongyu.jin@uhn.ca 416-340-4800 Official trial record

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