Not yet recruitingNAINTERVENTIONAL

Apneic Oxygenation With High-flow Nasal Oxygenation After Preoxygenation With Noninvasive Ventilation Before Intubation in Hypoxemic Patients in Intensive Care Unit.

This research is about a new approach to giving oxygen to very ill patients in intensive care who need help breathing through a tube, a procedure called intubation. Sometimes, oxygen levels can drop low during this important process. The study wants to find out if giving a continuous flow of oxygen through a special nose cannula, called High-Flow Nasal Oxygen (HFNO), during a specific part of the intubation can keep oxygen levels more stable. They are comparing this extra oxygen to the usual care, where no oxygen is given at that moment. The goal is to see if this new method can reduce the risk of patients getting dangerously low oxygen levels in their blood during intubation.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University Hospital, Tours

Enrolment target

500

Start

30 Oct 2025

Estimated completion

30 Nov 2028

Hypoxemic Acute Respiratory Failure

What is this study about?

When people are very unwell and struggling to breathe, doctors often need to insert a breathing tube into their windpipe. This procedure is called intubation. It's a vital step to help patients get the oxygen they need and can be done in an intensive care unit (ICU). During intubation, there's a small window of time when a patient might not be breathing on their own, and their oxygen levels can drop too low. This can be serious and, in some cases, lead to other problems like heart issues.

To try and prevent these drops in oxygen, doctors prepare patients by giving them extra oxygen beforehand, often using a special mask called non-invasive ventilation (NIV). This study is exploring an additional step during the intubation process itself. They are looking at a technique called 'apneic oxygenation' using a device called High-Flow Nasal Oxygen (HFNO). HFNO delivers a strong, continuous flow of oxygen through small tubes placed in the nose.

The main question this study wants to answer is whether giving this continuous HFNO during the brief period between when a camera is inserted into the throat (laryngoscopy) and when the breathing tube is successfully placed (intubation) can help keep oxygen levels higher. This is compared to the current standard approach where no extra oxygen is given during these few moments. Researchers hope this additional oxygen support could make the intubation procedure safer for patients already struggling with low oxygen.

Key takeaways

Tests if extra oxygen during intubation can improve safety.
Compares High-Flow Nasal Oxygen (HFNO) to standard care.
Aims to prevent dangerously low oxygen levels in very sick patients.
Involves patients in intensive care units needing breathing support.
Participation decided during urgent medical procedures.
Results could help make intubation safer in the future.

Who may be eligible?

To be considered for this study, you would need to be an adult patient admitted to an intensive care unit (ICU) and require intubation because you are experiencing severe breathing difficulties and low oxygen levels.

There are also some reasons why you might not be able to join. For example, if you are under 18 years old, if you need intubation immediately in an emergency like a cardiac arrest, or if you have certain medical conditions or allergies that make it unsafe for you to receive the study's treatments or pre-intubation procedures.

Also, if you've already taken part in this specific study before, you wouldn't be able to join again. Participants need to provide consent, either themselves or through a family member, to be part of the research.

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 (18 years or older)?
Are you currently in an intensive care unit (ICU)?
Do you need to have a breathing tube (intubation) because of severe breathing problems and low oxygen?
Could you or your family provide permission to take part?
Do you *not* need emergency intubation right this second for a cardiac arrest?
Do you *not* have any allergies to the medications used for intubation?

Answer every question to see your result.

What does participation involve?

If you join this study, your involvement would happen during the intubation procedure itself. All patients in the study will first receive standard oxygen preparation using a mask called non-invasive ventilation (NIV).

If you are in the experimental group, just before the breathing tube is placed, the NIV mask will be removed, and special oxygen tubes from a High-Flow Nasal Oxygen (HFNO) machine will be placed in your nostrils to provide a continuous flow of high-flow oxygen during the intubation. If you are in the control group, you will receive the usual care, meaning no additional oxygen will be given through the nose during this specific part of the intubation. The study measurements will focus on your oxygen levels during the intubation and for a few minutes afterwards. There are no additional visits or long-term follow-up specifically for this study beyond your usual ICU care.

Potential risks and benefits

Taking part in this study may offer the potential benefit of a reduced risk of dangerously low oxygen levels during intubation, which could lead to a smoother and safer procedure. However, there is no guarantee you will personally benefit. Potential risks are generally low, as the intervention involves providing oxygen, but as with any medical procedure in intensive care, complications can occur. You are always free to withdraw from the study at any time without affecting your medical care.

Locations (1)

CHRU de Tours
Verified postcode
Tours, France

Common questions

What is 'intubation'?

Intubation is when a doctor gently places a breathing tube into your windpipe to help you breathe, usually connecting it to a machine.

What is 'High-Flow Nasal Oxygen' (HFNO)?

HFNO is a way of giving oxygen through small tubes in your nose at a high speed to help you breathe easier and get more oxygen.

Am I guaranteed to get the new treatment if I join?

No, participants are randomly assigned to either receive the new oxygen method or the standard care, like flipping a coin.

Will this study affect my usual care in the ICU?

Your overall ICU care will continue as normal. This study specifically looks at one part of the intubation procedure.

What does 'hypoxemic acute respiratory failure' mean?

It means you are very unwell because your lungs aren't working properly, leading to dangerously low levels of oxygen in your blood.

How to find out more

Mai-Anh Nay, MD

mainah.nay@chu-orleans.fr +33 2 38 57 52 53 Official trial record

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