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

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Les Hopitaux De Chartres Le Coudray France
Centre Hospitalier De Perpignan Perpignan France
Centre Hospitalier Universitaire d’Orléans Orléans France
Centre Hospitalier Le Mans Le Mans France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier De Cholet Cholet France
Centre Hospitalier De Bourg-En-Bresse Bourg En Bresse France
Centre Hospitalier Bretagne Atlantique Vannes France
Centre Hospitalier De Dax Dax France
Centre Hospitalier de Dieppe Dieppe France
Hopital Nord Franche-Comte Belfort France
Cfigvn Hgaqqbewxwv Ubztliuboofpn Dm Diszt Dijon France
Cgaxsm Hfpngvrdkge Royzdulb Ukvzaffptsaes Du Ttlkr Tours France
Cmyvnc Hnrnppupeep Rpjwpvsp Dgufcvhtoomgje Angers France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
15.09.2025

Trial locations

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.

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 ID:
2024-514949-11-00
Protocol code:
DR240020
Trial Phase:
Therapeutic confirmatory (Phase III)

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