All studies
RecruitingNAINTERVENTIONAL

Non-Invasive Ventilation Versus High-flow Nasal Oxygen in Intensive Care Units

Patients in intensive care units (ICUs) sometimes have trouble breathing after their breathing tube is taken out, and a significant number might need the tube put back in, which can be very serious. Doctors are trying to find the best way to help these patients without needing to put the tube back in. This study looks at two types of breathing support: non-invasive ventilation (NIV), which uses a mask, and high-flow nasal oxygen, which delivers oxygen through the nose at a high rate. The research team wants to see if using NIV together with high-flow nasal oxygen, compared to high-flow nasal oxygen alone, can improve the chances of survival for patients who struggle with breathing after their tube is removed.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Poitiers University Hospital
Enrolment target
670
Start
02 Feb 2023
Estimated completion
27 Aug 2028

What is this study about?

When patients in intensive care units (ICUs) have a breathing tube removed after being on a ventilator, about 1 in 5, or 20%, find it hard to breathe on their own afterwards. This difficulty is called 'post-extubation respiratory failure'. If a patient can't breathe well enough, they might need the tube put back in, which happens to nearly half of these patients and can lead to a higher risk of death. Doctors are looking for the best way to support these patients so they don't have to go back on a ventilator.

Currently, there's some debate about the best treatment. One option is Non-Invasive Ventilation (NIV), where a mask is used to help with breathing. Some previous research has suggested that if NIV is used as a rescue treatment after breathing problems have already started, it might actually make things worse by delaying the decision to put the breathing tube back in when it's really needed. However, other recent studies have shown that NIV is often used and can help some patients avoid needing the breathing tube again, especially those with long-term lung conditions.

Another type of support is high-flow nasal oxygen, which delivers warm, moist oxygen through tubes placed in the nostrils at a high flow rate. This study aims to compare two approaches: giving patients both NIV (alternating with high-flow nasal oxygen) versus giving them high-flow nasal oxygen only. The main goal is to find out which of these strategies can reduce the risk of death for patients who experience breathing difficulties after their breathing tube is removed in the ICU.

Key takeaways

  • The study explores better breathing support methods in intensive care units (ICUs) after a breathing tube is removed.
  • It compares two approaches: Non-Invasive Ventilation (NIV) alternating with high-flow oxygen, versus high-flow oxygen alone.
  • The main goal is to reduce the risk of death for patients struggling to breathe after extubation.
  • Participation involves receiving one of these breathing supports while closely monitored.
  • This research aims to improve patient care and outcomes in critical situations.

Who may be eligible?

To be able to join this study, patients must have been on a breathing machine in the ICU for more than 24 hours before their breathing tube was removed. They also need to develop breathing difficulties within the first seven days after the tube is taken out. These breathing problems are clearly defined by breathing faster than 25 breaths per minute or showing signs of working harder to breathe for at least 30 minutes, combined with changes in their blood gas levels that show low oxygen or too much acid in the blood.

However, some conditions would mean a patient cannot join. This includes if they already use NIV at home, if their ICU stay is due to certain muscle or nerve conditions like Guillain-Barré syndrome, or if their breathing problem is mainly caused by a blockage in their upper airway. Patients also can't be in the study if they need the breathing tube put back in urgently (for example, if they have a cardiac arrest), if their consciousness is severely affected, if their breathing tube already came out by accident, or if they have a 'do not reintubate' order in place. The study is for adults over 18 and includes people of all sexes.

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.

  1. Are you over 18 years old?
  2. Were you on a breathing machine for more than 24 hours before your breathing tube was removed?
  3. Did you start having trouble breathing within 7 days after the breathing tube was taken out (like breathing very fast or showing signs of struggling)?
  4. Are your breathing problems not caused by a blockage in your upper airway?
  5. Are you not currently receiving breathing support through a mask (NIV) at home?
  6. Do you not have a 'do not reintubate' order in place?
Answer every question to see your result.

What does participation involve?

This clinical trial is evaluating different breathing support methods for patients in intensive care units. If a patient is eligible and agrees to participate, their breathing will be supported using either high-flow nasal oxygen alone or a combination of non-invasive ventilation (NIV) and high-flow nasal oxygen. The study will closely monitor their breathing, vital signs, and overall condition to see how well each method works. The main focus will be on their health outcomes and survival. The total duration of participation depends on how long the breathing difficulty lasts and the patient's recovery, but the interventions are typically used during the critical period after breathing tube removal in the ICU.

Potential risks and benefits

Participating in this study might offer the benefit of receiving carefully monitored and potentially more effective breathing support, which could improve recovery after having a breathing tube removed. However, there are potential risks associated with any medical intervention, and the study aims to compare established methods. For example, some past research suggested that non-invasive ventilation might delay reintubation if needed, which could be harmful in some cases. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (47)

  • Erasme Hospital
    Verified postcode
    Brussels, Belgium· Recruiting
  • Angers University Hospital
    Verified postcode
    Angers, France· Recruiting
  • Victor Dupouy Hospital
    Verified postcode
    Argenteuil, France· Recruiting
  • Henri Mondor Hospital
    Verified postcode
    Aurillac, France· Recruiting
  • Henri Duffaut Hospital
    Verified postcode
    Avignon, France· Recruiting
  • Nord-Franche-Comté Hospital
    Verified postcode
    Belfort, France· Recruiting
  • Bordeaux University Hospital
    Verified postcode
    Bordeaux, France· Withdrawn
  • Fleyriat Hospital
    Verified postcode
    Bourg-en-Bresse, France· Recruiting
  • Brest University Hospital
    Verified postcode
    Brest, France· Recruiting
  • Clermont-Ferrand University Hospital
    Verified postcode
    Clermont-Ferrand, France· Recruiting
  • Louis Mourier Hospital
    Verified postcode
    Colombes, France· Recruiting
  • Cèdres Clinic
    Verified postcode
    Cornebarrieu, France· Recruiting

Common questions

What does 'extubation' mean?

'Extubation' simply means taking out a breathing tube that was placed in your windpipe to help you breathe, usually after you've been on a ventilator.

What is 'respiratory failure'?

It means your lungs aren't working well enough to get oxygen to your blood or remove carbon dioxide, making it hard to breathe on your own.

What is 'Non-Invasive Ventilation (NIV)'?

NIV is a type of breathing support that uses a mask (over your nose or nose and mouth) to give you extra air pressure to help you breathe without needing a tube down your throat.

What is 'high-flow nasal oxygen'?

This is a treatment where warm, humidified oxygen is delivered through small tubes placed in your nostrils at a higher flow rate than standard oxygen, to help you breathe more comfortably.

Why is it important to find the best breathing support after extubation?

Many patients struggle to breathe after a breathing tube is removed, and finding the best support can help them avoid needing the tube put back in, which can be very serious and increases health risks.

How to find out more

Arnaud W. THILLE

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

Interested in taking part?

Register your interest

Share your details and the research team for "Non-Invasive Ventilation Versus High-flow Nasal Oxygen in In…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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