RecruitingOBSERVATIONAL

Pressure Muscle Index and Threshold of Over-assistance During Pressure Support Ventilation

This study is for patients in intensive care who need help breathing due to severe lung problems. It explores how to optimally adjust a breathing machine, called a ventilator. Ventilators provide 'pressure support' to help patients breathe, but it's important to give just enough – not too little, not too much. Too much support can weaken breathing muscles, while too little can make breathing too hard. Researchers are testing a new tool, the Pressure Muscle Index (PMI), which can be easily seen on the ventilator. This tool helps doctors find the perfect balance so patients' lungs and breathing muscles are protected, helping them get off the ventilator as quickly and safely as possible. This is the first time this tool is being studied in patients with serious lung injuries.

At a glance

Status

Recruiting

Sponsor

Unity Health Toronto

Enrolment target

Start

04 Oct 2024

Estimated completion

28 Feb 2026

Acute Hypoxemic Respiratory Failure

What is this study about?

When someone is seriously ill and needs help breathing, they might be connected to a machine called a ventilator. This machine gently pushes air into their lungs. This study is all about finding the best way to set up this breathing support, specifically a type called 'pressure support ventilation'. The goal is to make sure the patient's breathing muscles get just the right amount of help.

Think of it like riding a bike with assistance. You want enough help to make it easier, but not so much that your legs don't do any work at all. If the ventilator gives too much help, the patient's own breathing muscles might become weak. If it gives too little, the patient has to work too hard, which can be tiring and harmful. The researchers are using a new measurement called the Pressure Muscle Index (PMI) to fine-tune this support. They believe this index, which is easy to see on the ventilator screen, can help doctors find that perfect balance.

The main aim is to protect the patient's lungs and diaphragm (the main breathing muscle) and help them recover quickly so they can breathe on their own again. This study will be the first to test if using the PMI to guide ventilator settings can really make a difference for patients with severe lung problems, helping them get better and come off the breathing machine as soon as possible.

Key takeaways

This study aims to improve ventilator settings for seriously ill patients.
It uses a new tool, the Pressure Muscle Index (PMI), to find the best breathing support.
The goal is to protect lungs, strengthen breathing muscles, and help patients recover faster.
The study involves adjusting breathing machine settings, not new medications.
It could lead to better care for patients needing breathing support in the future.

Who may be eligible?

This study is looking for adults aged 18 or over who are currently in the intensive care unit and are connected to a breathing machine (ventilator). To be eligible, you must have severe breathing difficulties because your lungs aren't working well enough to get enough oxygen.

There are certain reasons why someone might not be able to join. This includes if they have a heart pacemaker, severe burns, or wounds that would prevent the use of special monitoring equipment. Also, if a patient has serious brain or nerve problems that were diagnosed before their current illness, or if they are very restless or agitated, they would not be able to take part.

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 intensive care and on a breathing machine?
Do you have severe breathing difficulties due to lung problems?
Do you not have a pacemaker or other device that would interfere with monitoring?
Do you not have severe, pre-existing brain or nerve conditions?
Are you not overly agitated or restless?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, the study will involve a series of adjustments to your breathing machine settings, each lasting about 5 minutes. Doctors will carefully measure your breathing and how your lungs are working at different settings. During some of these measurements, they might temporarily pause your breathing machine for a few seconds to get specific readings – this is a standard and safe procedure. Before and after these short pauses, your regular breathing support will be resumed.

The entire study procedure will take about 60 minutes in total. Throughout this time, you will be continuously monitored by the intensive care team. There are no new medications involved; it's all about adjusting how your current breathing machine is set.

Potential risks and benefits

Taking part in this study could help doctors learn how to provide better breathing support for patients like you in the future. While there's no guarantee of direct benefit, optimising ventilator settings may potentially lead to a faster recovery and less time on the breathing machine. The study involves adjusting existing ventilator settings, which is done under close medical supervision. There's a small risk that some settings might be less comfortable temporarily, but the medical team will watch you closely and can stop any step if it's not tolerated well. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

St. Michael's Hospital
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is a ventilator?

A ventilator is a machine that helps you breathe when your lungs are too sick to do it on their own completely. It gently pushes air into your lungs.

What does 'pressure support' mean?

Pressure support is a type of help the ventilator gives. It adds a bit of pressure to each breath you take, making it easier for you to inhale.

What is the Pressure Muscle Index (PMI)?

The PMI is a new measurement that doctors can see on the ventilator. It helps them understand how much effort your breathing muscles are making and if the ventilator is giving you the right amount of help.

Will this study give me new medicine?

No, this study does not involve any new medicines. It's focused on finding the best ways to set up the breathing machine you are already using.

How long will the study procedures take?

The tests for this study are expected to take about an hour, during which you will be continuously monitored by the medical staff.

How to find out more

Laurent Brochard, MD, PhD

laurent.brochard@unityhealth.to 4168645686 Official trial record

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