RecruitingNAINTERVENTIONAL

Weaning Protocol for High-flow Nasal Oxygen Therapy in Intensive Care

This study is investigating a new approach to help intensive care patients who are receiving oxygen through tubes in their nose (called high-flow nasal oxygen, or HFNO). When patients are taken off this support, it's called 'weaning.' The goal of this research is to see if using a special step-by-step plan for weaning patients off HFNO increases their chances of breathing independently by day 7 after starting the plan. This could help patients avoid needing more serious breathing machines. The study will compare patients who follow this new weaning plan with those who receive standard care, to understand if the plan makes a difference to their recovery.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Tours

Enrolment target

370

Start

17 Feb 2024

Estimated completion

01 Mar 2027

Acute Hypoxemic Respiratory Failure High-flow Nasal Oxygen Therapy

What is this study about?

When people are very unwell and struggling to breathe, especially if their lungs aren't getting enough oxygen into their blood, they might be given something called high-flow nasal oxygen (HFNO). This is a way of giving extra oxygen and helps support their breathing through soft tubes placed in their nose.

Once a patient starts to recover, doctors need to gradually reduce this support so the patient can start breathing fully on their own again. This process is known as 'weaning.' The aim of this study is to find out if using a specific, step-by-step plan for weaning patients off high-flow oxygen helps them recover faster and reduces their need for more advanced types of breathing support, such as a breathing machine (ventilator).

Researchers want to see if patients who follow this new weaning plan are more likely to be breathing on their own without high-flow oxygen by day 7 compared to patients receiving the usual care. They will also keep an eye on patients for up to 28 days to see how they continue to do. This research is important because if the new plan works, it could help many patients in intensive care units recover better and potentially go home sooner.

Key takeaways

The study aims to improve how patients are taken off high-flow oxygen.
It compares a new step-by-step weaning plan with standard care.
The goal is to help patients breathe on their own sooner, by day 7.
This could help avoid more invasive breathing support.
Participation involves monitoring your recovery for up to 28 days.

Who may be eligible?

To be able to take part in this study, you generally need to be an adult patient (aged 18 to 90) who has been admitted to an intensive care unit because you're having trouble getting enough oxygen into your blood. You would have been receiving high-flow nasal oxygen (HFNO) for at least 24 hours, and your condition should be stable or improving. You'd also need to be able to provide consent, either yourself or through a family member, with you confirming it later if possible.

There are also some reasons why you might not be able to join. These include if you have certain existing lung conditions like severe emphysema (chronic obstructive pulmonary disease), or if your breathing problems are mainly due to heart failure. You also wouldn't be able to join if you are pregnant or breastfeeding, already on long-term breathing support at home, or if doctors have decided not to use a breathing machine for you.

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 an adult aged 18 to 90?
Are you currently in intensive care due to breathing problems?
Have you been on high-flow nasal oxygen for at least a day?
Is your breathing condition stable or getting better?
Are you or your closest family able to give permission to take part?

Answer every question to see your result.

What does participation involve?

If you join this study, you will either follow a new, specific plan for reducing your high-flow nasal oxygen, or you will continue with the standard care given by your medical team. This choice will be made randomly, like flipping a coin. The specific weaning plan will begin once your doctors believe you are stable enough to start reducing your oxygen support. You won't receive new medications as part of this study, but your doctors will continue to manage your overall health.

You will be closely watched by your healthcare team as usual. The main thing researchers will be looking at is whether you can stop using high-flow nasal oxygen by day 7 after the study starts for you, without needing other types of breathing help. You will be monitored for up to 28 days to see how your breathing continues to improve.

Potential risks and benefits

Potential benefits of taking part could include receiving a structured weaning plan that might help you breathe independently sooner, potentially reducing the time you need supportive oxygen therapy. However, there's no guarantee the new plan will be better than standard care. Risks are generally low, as both groups receive careful medical attention, and neither involves experimental drugs. The main difference is the method of gradually reducing oxygen. As with any medical care, your doctors will monitor you closely for any changes. You are free to withdraw from the study at any time without affecting your medical care.

Locations (11)

Intensive care, University Hospital, Blois
Verified postcode
Blois, France· Recruiting
Intensive care unit, University Hospital, Bourg-en-Bresse
Verified postcode
Bourg-en-Bresse, France· Recruiting
Intensive care, University Hospital, Bourges
Verified postcode
Bourges, France· Recruiting
Intensive care unit, University Hospital, Caen
Verified postcode
Caen, France· Not yet recruiting
Intensive care, University Hospital, Chartres
Verified postcode
Chartres, France· Recruiting
Intensive care, University Hospital, Cholet
Verified postcode
Cholet, France· Recruiting
Intensive care, University Hospital, Dax
Verified postcode
Dax, France· Recruiting
Intensive care, University Hospital, Le Mans,
Verified postcode
Le Mans, France· Recruiting
Intensive care, University Hospital, Orléans
Verified postcode
Orléans, France· Recruiting
Intensive care, University Hospital, Tours
Verified postcode
Tours, France· Recruiting
Intensive care unit, University Hospital, Vannes
Verified postcode
Vannes, France· Recruiting

Common questions

What is high-flow nasal oxygen therapy (HFNO)?

HFNO is a way to give you extra oxygen and breathing support through soft tubes in your nose when you're struggling to breathe.

What does 'weaning' mean in this study?

Weaning means gradually reducing the amount of oxygen and support you're getting from the HFNO so you can start breathing independently again.

Will I get new medication if I join this study?

No, this study is about how to reduce oxygen support, not about new medications. You will still receive all your usual care and any necessary medicines.

How long will I be involved in the study?

You will be monitored for up to 28 days after you start the weaning process, to see how you are recovering.

Can I leave the study if I change my mind?

Yes, you can decide to leave the study at any time, and it will not affect the medical care you receive.

How to find out more

Mai-Anh NAY, MD

mai-anh.nay@chr-orleans.fr 02.38.51.44.46 Official trial record

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