HNFO With or Without Helmet NIV for Oxygenation Support in Acute Respiratory Failure Pilot RCT
This study, called a randomised control trial, aims to find the best way to help patients who are very ill and struggling to breathe due to a condition called acute hypoxemic respiratory failure. We are comparing two methods. One group of patients will receive oxygen through a special helmet, along with high-flow oxygen through tubes in their nose. The other group will only receive the high-flow oxygen through their nose. Doctors will closely monitor patients to see which approach is more effective in helping them get enough oxygen and recover. This is a pilot study, meaning it's a first step to understand these treatments better.
At a glance
What is this study about?
This study is looking into the best ways to help people who are having a really tough time breathing. When your lungs can't get enough oxygen into your blood, it's called acute hypoxemic respiratory failure. It can be very serious and often means you need to be in intensive care.
The trial wants to compare two different ways of giving oxygen support. One way uses a special helmet that fits over your head and helps push air and oxygen into your lungs (this is called Helmet Non-Invasive Ventilation or HNIV). This will be used in sessions throughout the day, with other times using high-flow nasal oxygen (HFNO), which delivers oxygen through small tubes placed just inside your nose. The other group will receive only the high-flow nasal oxygen.
By comparing these two methods, doctors hope to learn which one is more effective at helping people breathe better and avoid needing a breathing tube placed down their throat (a process called intubation). This is a 'pilot' study, which means it's a smaller, early study designed to help plan future, larger research.
Key takeaways
- This study compares two oxygen treatments for severe breathing problems.
- It's for patients in intensive care with low oxygen levels.
- One group gets helmet oxygen and nasal oxygen; the other just nasal oxygen.
- The goal is to find which treatment helps patients breathe better.
- A follow-up call will check on your health six months later.
Who may be eligible?
To join this study, you would need to be at least 18 years old and currently receiving care in an intensive care unit (ICU). You must be experiencing severe breathing difficulties where your body isn't getting enough oxygen, and these problems must have started fairly recently (within the last 14 days).
There are also some important reasons why you might not be able to join. For example, if your doctors think you need a breathing tube straight away, or if you have certain medical conditions that would make the treatments unsafe for you. Also, if you've recently been taken off a breathing tube in the ICU, or if you're already receiving high levels of oxygen support for a long time, you might not be suitable.
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 or older?
- Are you currently in intensive care due to severe breathing difficulties?
- Have your breathing problems started within the last 14 days and are still present?
- Are you not currently on a breathing tube or expected to need one right away?
- Have you not had a breathing tube removed in the last 3 days?
What does participation involve?
If you decide to take part, you'll be assigned by chance to one of two groups. One group will get oxygen treatment using a special helmet for at least 12 hours a day, alongside oxygen through your nose. The other group will only receive oxygen through your nose, also for at least two days. You won't know which treatment you're getting until after you've joined the study.
Doctors and nurses will closely monitor your progress during your hospital stay, which could be up to 60 days. After you leave the hospital, there will be one follow-up phone call about six months later to ask about your general health and how you're feeling. There are no extra hospital visits required beyond your normal care.
Potential risks and benefits
Locations (11)
- University of CalgaryVerified postcodeCalgary, Canada
- University of Alberta HospitalVerified postcodeEdmonton, Canada
- Hamilton Health Sciences- JuravinskiVerified postcodeHamilton, Canada
- Kingston General HospitalVerified postcodeKingston, Canada
- London Health Sciences CentreVerified postcodeLondon, Canada
- Ottawa HospitalVerified postcodeOttawa, Canada
- North York General HospitalVerified postcodeToronto, Canada
- Sunnybrook Health Sciences CentreVerified postcodeToronto, Canada
- St. Michael's HospitalVerified postcodeToronto, Canada
- Mount Sinai HospitalVerified postcodeToronto, Canada
- University Health Network Toronto GeneralVerified postcodeToronto, Canada
Common questions
What is 'Acute Hypoxemic Respiratory Failure'?
It means your lungs are having trouble getting enough oxygen into your blood, making it hard to breathe.
What is the difference between the two treatments?
One uses a special helmet to help you breathe, along with nose oxygen. The other uses only the nose oxygen.
Will I know which treatment I'm getting?
No, you'll be assigned to a treatment by chance, and you won't know which one for a while.
How long will I be in the study?
You'll be monitored until you leave the hospital, or for up to 60 days, with one phone call at 6 months.
Can I stop participating if I want to?
Yes, you can leave the study at any time, and it won't affect your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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