Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study of High-Flow Nasal Oxygen During Intubation in Intensive Care Patients with Low Blood Oxygen Levels

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with hypoxemic acute respiratory failure, a condition where the body doesn't get enough oxygen, causing breathing difficulties and low oxygen levels in the blood. The research examines the use of high-flow nasal oxygenation during a medical procedure called intubation, where a breathing tube is inserted into the airway. The main treatment being studied is medical oxygen delivered through specialized equipment.

The purpose of the study is to determine if providing oxygen through the nose during the intubation procedure can reduce the occurrence of dangerously low oxygen levels in patients who are already having difficulty breathing. Patients will be divided into two groups - one receiving the nasal oxygen treatment during intubation, and another group receiving standard care without additional oxygen.

During the study, medical staff will monitor oxygen levels in the blood and track any complications that may occur during and after the breathing tube placement. The treatment involves using up to 60 liters of oxygen per day through specialized breathing equipment. Patients will be followed for 28 days after the procedure to assess their recovery.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    You will be assessed for hypoxemic acute respiratory failure, which means you have difficulty breathing and low oxygen levels in your blood

    Your doctor will check if you have rapid breathing (more than 25 breaths per minute), shortness of breath, or are using extra muscles to breathe

    A blood test will be performed to measure your oxygen levels

  2. Step 2

    Preparation for intubation

    Your doctor will determine that you need a breathing tube (orotracheal intubation)

    You will receive oxygen through a special mask called noninvasive ventilation to improve your oxygen levels before the procedure

  3. Step 3

    Intubation procedure

    You will be assigned to receive either additional oxygen through your nose during the procedure (high-flow nasal oxygen) or standard care

    Your oxygen levels will be continuously monitored through a device on your finger that measures oxygen saturation

    The doctor will insert a breathing tube through your mouth into your airway

    The entire procedure will be monitored for up to 5 minutes after the tube is successfully placed

  4. Step 4

    Monitoring period

    Your vital signs, including heart rate and blood pressure, will be closely monitored

    A chest X-ray will be taken as part of routine care

    Your health status will be tracked for 28 days after the procedure

Who can join the trial?

10 criteria

  • Must be an adult patient (18 years or older) admitted to the Intensive Care Unit (ICU)
  • Must require orotracheal intubation (insertion of a breathing tube through the mouth)
  • Must have hypoxemic acute respiratory failure with:
    • At least one sign of breathing difficulty such as:
      • Fast breathing (more than 25 breaths per minute)
      • Feeling short of breath
      • Using extra muscles to breathe
      • AND low oxygen levels measured by a specific ratio (PaO2/FiO2) of 200 or less within 6 hours before deciding to intubate
      • Must be able to provide informed consent, either:
        • Directly from the patient
        • From family members or relatives
        • Through emergency consent procedures when necessary
        • Can be either male or female

Who cannot join the trial?

14 criteria

  • Age under 18 years old
  • Pregnancy or breastfeeding women
  • Patients with severe facial trauma that prevents normal intubation
  • Patients with known anatomical airway abnormalities that make intubation difficult
  • Emergency situations requiring immediate intubation without time for study procedures
  • Patients who cannot give informed consent and have no legal representative available
  • Patients with upper airway obstruction (blockage in the throat or voice box area)
  • Previous participation in this clinical trial
  • Patients with cervical spine instability (unstable neck bones)
  • Known allergy to any medications used in the intubation procedure
  • Patients who are hemodynamically unstable (having unstable blood pressure or heart function)
  • Active bleeding in the mouth or throat
  • Patients who require special intubation techniques
  • Inability to lie flat on the back for the procedure
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

High-Flow Nasal Oxygenation (HFNO) is a type of oxygen therapy that delivers warm, humidified oxygen through nasal cannulas at high flow rates. This therapy helps patients breathe more easily by providing a constant flow of oxygen. It's commonly used in intensive care settings for patients who need respiratory support. Non-invasive Ventilation (NIV) is a method of providing breathing support through a mask that fits over the nose or mouth, without requiring insertion of a breathing tube. This therapy helps patients get more oxygen while reducing the work of breathing. It's particularly useful for patients with respiratory difficulties who need temporary breathing assistance. These therapies are being compared to evaluate their effectiveness in maintaining oxygen levels during the intubation procedure in patients who have difficulty breathing and low oxygen levels in intensive care.

What is already known about the treatment

  • High-Flow Nasal Oxygen (HFNO)

    A non-invasive respiratory support device that delivers heated and humidified oxygen through nasal cannulas at high flow rates, typically between 30-60 liters per minute. This medical intervention is currently widely used in intensive care units for treating patients with acute hypoxemic respiratory failure, providing better oxygenation than traditional oxygen therapy. HFNO works by creating a positive airway pressure effect and reducing anatomical dead space, while also providing comfortable and well-tolerated oxygen delivery to patients who are experiencing breathing difficulties. It belongs to the class of respiratory support devices and serves as a bridge therapy during pre-intubation oxygenation, helping to maintain oxygen saturation during critical procedures.

  • Noninvasive Ventilation (NIV)

    A form of mechanical ventilation delivered through a tight-fitting face mask or nasal mask without the need for endotracheal intubation. This established respiratory support method is commonly used in intensive care settings to treat acute respiratory failure and has shown significant benefits in preventing the need for invasive mechanical ventilation. NIV functions by providing positive pressure ventilation that helps expand the lungs, reduce breathing effort, and improve gas exchange, while allowing patients to remain conscious and maintain their natural airway protection mechanisms. It belongs to the category of non-invasive respiratory support devices and is particularly effective for pre-oxygenation before intubation procedures.

Investigated diseases

Hypoxemic Acute Respiratory Failure - A condition where the lungs cannot take in enough oxygen to meet the body's needs, resulting in low oxygen levels in the blood. It develops when there is damage to the lung tissue or when fluid builds up in the air sacs of the lungs. The condition can progress rapidly, causing difficulty breathing and increased breathing rate. Common symptoms include shortness of breath, rapid breathing, and a bluish tint to the skin or lips. The condition affects the normal exchange of gases in the lungs, specifically reducing the amount of oxygen that passes from the air sacs into the bloodstream.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514949-11-00Protocol codeDR240020Estimated enrolment500 patientsSponsorCentre Hospitalier Regional Universitaire De Tours

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.