RecruitingNAINTERVENTIONAL

Validation of a System Using Aerosol Glycerine to Detect and Localize Intraoperatively Pulmonary Air Leaks

This study is looking into a new method to find air leaks in the lung during an operation. Air leaks are a common issue after lung surgery and can make recovery longer and more difficult. Currently, it's hard for surgeons to spot these leaks during keyhole surgery. This new system uses a tiny amount of a special glycerine 'smoke' that is gently put into the patient's lungs. This smoke then comes out of any air leaks, making them easy for the surgeon to see using their traditional cameras. The aim is that by finding and fixing these leaks during surgery, patients will have fewer problems afterwards, spend less time in hospital, and recover more quickly.

At a glance

Status

Recruiting

Phase

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrolment target

200

Start

20 Jul 2023

Estimated completion

01 Jul 2027

Air Leak From Lung

What is this study about?

When people have surgery on their lungs, sometimes a small hole can form, allowing air to leak out. These 'air leaks' are fairly common and can lead to complications, meaning patients might have to stay in the hospital longer than expected and face a tougher recovery.

At the moment, surgeons have ways to check for these leaks. However, these methods don't always work well with modern keyhole surgery (called Video Assisted Thoracic Surgery or VATS), which is less invasive. Because of this, it can be tricky for surgeons to find and fix all the leaks during the operation itself.

This study is trying out a new approach to make air leaks easier to see. Doctors will use a specially designed system to deliver a very fine, visible mist (like a harmless, thin 'smoke') made of glycerine into your lungs. If there's an air leak, this mist will come out of it, making the leak stand out clearly on the surgeon's camera screen. The hope is that by seeing these leaks better, surgeons can fix them straight away, leading to a smoother recovery, fewer problems, and shorter hospital stays for patients undergoing lung operations.

Key takeaways

Tests a new method to find air leaks during lung surgery.
Uses a special, safe glycerine mist to highlight leaks.
Aims to improve patient recovery and reduce hospital stays.
Only affects what happens during your planned operation.
Suitable for adults having lung transplant surgery.

Who may be eligible?

To be part of this study, you would need to be an adult over 18 years old. Importantly, you would be a patient who is preparing for lung transplant surgery. This doesn't mean you are donating a lung yourself, but rather you are receiving a donated lung.

Also, a specific group of people who are organ donors, but whose lungs cannot be used for donation, might also be considered for this study, as it helps test the system.

You would not be able to join this study if you are a healthy person not undergoing any surgery, or if you are outside the specified age range.

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 scheduled for lung transplant surgery?
Are you *not* a healthy individual undergoing no surgery?

Answer every question to see your result.

What does participation involve?

This study is designed to test a new method during planned lung surgery. If you participate, the main difference for you would be the use of this new glycerine aerosol system during your operation to help the surgeons find any air leaks. This is done while you are already under anaesthetic for your surgery. There are no additional visits or follow-up appointments specifically for this study beyond what would normally be expected for your surgery and recovery. The total duration of your participation is essentially limited to the time of your surgery.

Potential risks and benefits

The potential benefit of this study is for future patients, as it could lead to a better way for surgeons to find and fix air leaks during lung surgery. This might mean fewer complications, faster recovery, and shorter hospital stays for them. For you, as a participant, the potential direct benefit is minimal, as the system is being tested. However, knowing that your participation helps improve surgical methods for others can be rewarding. As with any new procedure, there are potential small risks, though the glycerine aerosol is designed to be safe. You have the right to withdraw from the study at any time without it affecting your medical care.

Locations (1)

CHUM
Verified postcode
Montreal, Canada· Recruiting

Common questions

What exactly is an 'air leak'?

An air leak is when a small amount of air escapes from your lung after surgery, which can slow down healing.

What is glycerine 'smoke'?

It's not real smoke, but a very fine mist made of glycerine, which is harmless and helps surgeons see tiny air leaks clearly.

Will I feel anything different during surgery?

No, you will be asleep under general anaesthetic, so you won't feel anything while the system is being used.

Does this study involve taking extra medicines?

No, this study only involves using the special glycerine mist system during your lung surgery, not any extra medicines.

How long will my hospital stay be because of this study?

The study aims to help reduce hospital stays in the future. For you, the study itself shouldn't make your stay any longer than usual.

How to find out more

Moishe Liberman, MD

moishe.liberman@umontreal.ca 514-890-8000 Official trial record

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