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Study on Weaning Patients with Acute Respiratory Failure from High-Flow Nasal Oxygen Therapy Using Oxygen

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on patients experiencing a condition known as acute respiratory failure, which occurs when the lungs cannot provide enough oxygen to the body's organs. The study is investigating a treatment method called High-Flow Nasal Oxygen Therapy, which delivers oxygen through a nasal cannula at a high flow rate to help patients breathe more easily. The main goal of the study is to determine if using a specific protocol can help patients successfully stop using this therapy within seven days.

Participants in the study will receive either the standard care or follow a new protocol designed to help them gradually reduce their dependence on high-flow nasal oxygen. The study will monitor patients over a period of up to 28 days to see how well they can be weaned off the therapy. Researchers will also track other outcomes, such as the need for additional breathing support, the length of stay in the intensive care unit, and overall recovery progress.

The study aims to improve the process of weaning patients from high-flow nasal oxygen therapy, potentially leading to better recovery outcomes for those with acute respiratory failure. By understanding how to effectively reduce the use of this therapy, the study hopes to enhance patient care and support recovery in the intensive care setting.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after meeting specific criteria, including being 18 years or older, admitted to the intensive care unit (ICU) for acute respiratory failure, and currently receiving high-flow nasal oxygen therapy.

    Consent must be provided, either by the patient or a designated representative if the patient is unable to do so.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to ensure stability or improvement in the ROX index, which measures oxygen levels and breathing rate.

    A gas measurement is taken within 24 hours of joining the study to confirm eligibility.

  3. Step 3

    Treatment with high-flow nasal oxygen

    Patients continue to receive high-flow nasal oxygen therapy, which involves a flow rate of at least 50 liters per minute and an inspired oxygen fraction of at least 0.5.

    This treatment is maintained for at least 24 hours in the ICU or continuous care unit.

  4. Step 4

    Weaning protocol

    The main objective is to increase the likelihood of weaning from high-flow nasal oxygen therapy by day 7 after randomization.

    Success is defined as being weaned for more than 48 hours without needing additional ventilation support and being alive at day 7.

  5. Step 5

    Monitoring and evaluation

    Throughout the study, various factors are monitored, including the rate of weaning by day 28, time to definitive weaning, and any need for intubation or non-invasive ventilation.

    Other evaluations include the ROX index, use of respiratory muscles, and levels of breathlessness.

  6. Step 6

    Completion of study

    The study concludes with an assessment of the length of stay in the ICU and the ability to be discharged based on specific criteria.

    The study is estimated to end by October 4, 2026.

Who can join the trial?

8 criteria

  • The patient must be an adult, which means they are **18 years old or older**.
  • The patient must be admitted to the **ICU** (Intensive Care Unit) for a condition called **acute hypoxemic respiratory failure de novo**. This means they have trouble breathing because their blood oxygen levels are low, and this is a new problem for them.
  • The patient must be receiving **high-flow nasal oxygen therapy**. This is a treatment that delivers a high amount of oxygen through a tube in the nose. The flow rate must be **50 liters per minute or more**, and the oxygen level they are breathing in must be **50% or more**.
  • The patient's **ROX index** must be stable or getting better in the 6 hours before joining the study. The ROX index is a number that helps doctors understand how well the patient is breathing. It must be **greater than 4.88**.
  • The patient must have had a **gas measurement** while on high-flow nasal oxygen therapy within 24 hours before joining the study. This is a test to check the levels of gases like oxygen and carbon dioxide in the blood.
  • The patient must be part of a **social security scheme**. This means they have some form of health insurance or government health coverage.
  • The patient must provide **written consent** to participate. If the patient cannot do this themselves, a trusted person, parent, or close relative can sign for them. The patient must confirm this consent as soon as they are able.
  • The patient must have been treated with high-flow nasal oxygen for at least **24 hours** in an intensive care unit or a continuous care unit.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of breathing problem than the one being studied.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specific group being studied.
  • Patients who are considered part of a vulnerable population, which means they might need extra protection or care.
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Investigated drugs

High-Flow Nasal Oxygen Therapy is a treatment used in the intensive care unit (ICU) to help patients breathe more easily. It delivers a high flow of oxygen through a nasal cannula, which is a small tube placed in the nostrils. This therapy is often used for patients who have difficulty breathing on their own, providing them with the necessary oxygen support. The clinical trial aims to test a specific protocol to help patients gradually reduce their dependence on this therapy, increasing the chances of successful weaning by the seventh day after starting the trial.

What is already known about the treatment

High-Flow Nasal Oxygen Therapy – This therapy is administered through a nasal cannula, delivering a high flow of oxygen to patients. It is currently being studied in clinical trials, particularly for its effectiveness in weaning patients with acute respiratory failure. The main therapeutic indication is to support breathing in patients with respiratory distress. At the molecular level, it works by providing a constant flow of oxygen, which helps maintain adequate oxygen levels in the blood and reduces the work of breathing. It is classified under respiratory support therapies.

Investigated diseases

Acute Respiratory Failure – Acute respiratory failure occurs when the lungs cannot provide enough oxygen to the blood or remove carbon dioxide from the blood. This condition can develop suddenly and may be caused by various factors, including lung diseases, injuries, or infections. Symptoms often include difficulty breathing, rapid breathing, and confusion due to low oxygen levels. As the condition progresses, it can lead to increased heart rate and bluish skin due to lack of oxygen. The severity of symptoms can vary, and the condition requires immediate medical attention to address the underlying cause and support breathing.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504366-36-00Protocol codeDR230001Estimated enrolment370 patientsSponsorCentre Hospitalier Regional Universitaire De Tours

sourced from the EU Clinical Trials Register and site verification

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