RecruitingNAINTERVENTIONAL

VentilO Prospective Study

This research study, called VentilO, is looking at how we set up breathing support for adult patients in intensive care after heart surgery. When patients need help breathing, they are connected to a ventilator, which is a breathing machine. Doctors usually set the machine's controls, but this study compares that to settings suggested by a special computer application called VentilO. The main aim is to see if using the app’s suggested settings can help prevent a common problem called respiratory acidosis, which is when there’s too much acid in the blood due to breathing difficulties. We want to find the best way to help patients breathe and recover.

At a glance

Status

Recruiting

Phase

Sponsor

Laval University

Enrolment target

Start

24 Apr 2025

Estimated completion

01 Jun 2027

Mechanical Ventilation Complication Respiratory Acidosis

What is this study about?

When someone has a big operation like heart surgery and needs extra help to breathe, they often go into intensive care and are connected to a breathing machine, called a ventilator. This machine helps move air in and out of their lungs. Doctors and nurses carefully choose the settings for this machine, such as how many breaths per minute and how much air goes in with each breath. These settings are really important for the patient's recovery.

This study is trying to find the best way to set up these breathing machines immediately after a patient arrives in intensive care. We are comparing two approaches. In one group, doctors will set the machine as they usually would. In another group, a special computer program called VentilO will suggest the settings. We want to see if using the VentilO app's recommendations can lead to fewer breathing-related problems, specifically a condition called 'respiratory acidosis', which means the body has too much acid because of breathing issues.

By comparing these two methods, we hope to learn if using the VentilO app leads to better breathing outcomes for patients. This research could help improve how we care for people recovering from heart surgery and make sure they get the best possible breathing support.

Key takeaways

This study compares two ways to set up breathing machines for adults after heart surgery.
It aims to see if using a special app (VentilO) helps prevent breathing problems more effectively.
Your medical care will remain the highest priority, regardless of participation.
Taking part means the initial settings of your breathing machine might be chosen by a different method.
There are no extra tests or hospital visits for this study beyond your normal care.

Who may be eligible?

This study is designed for adult patients who have just had heart surgery and are admitted to the intensive care unit. To be considered, you must be at least 18 years old and need a breathing machine (ventilator) immediately after your surgery. The type of breathing machine you're on also needs to be in a specific controlled mode.

There are a few reasons why someone might not be able to join the study. If your doctors don't have your height and weight information readily available, or if you're already breathing mostly on your own when you arrive in intensive care, you wouldn't be able to take part. Also, if you've already had your breathing tube removed (called being 'extubated') before you arrive in intensive care, you wouldn't be eligible for 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 18 years old or older?
Have you just had heart surgery?
Do you need a breathing machine (ventilator) right after your surgery?
Is your height and weight information available in your medical records?
Are you not breathing mostly on your own when you arrive in intensive care?
Have you not had your breathing tube removed before arriving in intensive care?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, the main difference will be how your breathing machine settings are decided when you first arrive in intensive care. You might be in a group where your doctors choose the settings, or in a group where a special app, VentilO, helps suggest the settings. All other aspects of your care will remain the same, and your medical team will continue to monitor you closely. There are no extra visits or assessments specifically for this study beyond what you would normally receive as part of your intensive care treatment. The study intervention happens at the very beginning of your time in intensive care, and your progress will be monitored as part of your standard care.

Potential risks and benefits

Taking part in this study means your breathing machine settings might be chosen in a slightly different way initially. As this is a comparison between two ways of setting the machine, there are no known direct extra risks beyond those associated with standard ventilator care. A potential benefit is that we might learn more about the best way to set breathing machines, which could help you or future patients. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Verified postcode
Québec, Canada· Recruiting

Common questions

What is acidosis?

Acidosis is a medical term that means your body has too much acid in its blood. In this study, we're looking at 'respiratory acidosis,' which happens if you're not breathing out enough carbon dioxide, a waste product, from your lungs. It can make you feel unwell.

What is a ventilator?

A ventilator is a machine that helps you breathe when you can't do it well enough on your own. It pushes air into your lungs and helps you breathe out, making sure your body gets enough oxygen and removes waste gases.

What is the VentilO app?

VentilO is a computer application (like an app on a tablet) that could help doctors decide the best settings for a patient's breathing machine. This study is testing to see if it makes a positive difference.

Will I know if I'm in the app group or the doctor group?

This is an 'open-label' study, which means your medical team and the researchers will know which method is being used for your breathing machine settings. However, you might not directly notice a difference in your care.

Will my care change if I join this study?

No, your medical team will continue to give you the best possible care, regardless of whether you are in the study or not. The study only looks at how the initial breathing machine settings are chosen.

How to find out more

Francois Lellouche Principal investigator, MD, PhD

francois.lellouche@criucpq.ulaval.ca 1-418-656-8711 Official trial record

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