Hypoxemic Acute Respiratory FailureAPNEICNCT07189338
Apneic Oxygenation With High-flow Nasal Oxygenation After Preoxygenation With Noninvasive Ventilation Before Intubation in Hypoxemic Patients in Intensive Care Unit.
A study testing Apneic oxygenation in people with Hypoxemic Acute Respiratory Failure, run by University Hospital, Tours at 1 site in France.
Trial summary
The aim of this clinical study is to assess whether apneic oxygenation with High-Flow Nasal Oxygen (HFNO) would decrease the incidence of severe hypoxemia compared to no apneic oxygenation during the intubation procedure (from the start of laryngoscopy to 5 minutes after successful intubation) in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemic Acute Respiratory Failure
- What is being tested?
- Apneic oxygenation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 30 Oct 2025to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient admitted in the ICU
- Indication of orotracheal intubation for Hypoxemic acute respiratory failure defined by:
- One sign of acute respiratory distress (respiratory rate >25/min, dyspnea or the use of accessory respiratory muscle)
- AND a PaO2/FiO2 ≤ 200 mmHg (measured or calculated FiO2) within 6 hours before the decision of intubation. For the calculation of FiO2, the FiO2 will be estimated by: FiO2 = 0.21 + 0.03 x (flow of oxygen) (Coudroy, Thorax 2020)
- Informed consent from the patient or relatives. An emergency procedure will be possible when necessary.
Who cannot join
- < 18 years old
- Need for emergent intubation (i.e. cardiac arrest)
- Contraindication to non-invasive ventilation for preoxygenation
- Known allergy or contraindication to one of the induction drugs
- SpO2 device specific for the study not available
- Patients without any healthcare insurance scheme or not benefiting from it through a third party,
- Persons under law protection, namely minors, pregnant or breastfeeding women, persons deprived of their liberty by a judicial or administrative decision
- Previous participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHRU de Tours
Tours, 37000
Amélie DELAGE, +33 2 47 47 39 33, a.delage@chu-tours.fr
cpcq@chu-tours.fr
About this study
The aim of this clinical study is to assess whether apneic oxygenation with High-Flow Nasal Oxygen (HFNO) would decrease the incidence of severe hypoxemia compared to no apneic oxygenation during the intubation procedure (from the start of laryngoscopy to 5 minutes after successful intubation) in patients with hypoxemic acute respiratory failure.
The sponsor expects that apneic oxygenation (between the laryngoscopy and the success of intubation) with HFNO compared to no apneic oxygenation could decrease the risk of severe hypoxemia after intubation in hypoxemic critical ill patients.
Read more
Participants will be enrolled according to eligibility criteria and randomized into one of the following groups:
Experimental group : Apneic oxygenation will be used with HFNO between the laryngoscopy and the successful intubation (study intervention).
non-invasive ventilation (NIV) alone will be used for the preoxygenation and hypoventilation phase until the laryngoscopy. The nasal cannulas of HFNO will be placed on hold beneath the patient's chin (with HFNO on and set with a flow at 60-70L.min-1, FiO2 1.0) pending laryngoscopy began.
At the time of laryngoscopy: after removing the facemask of NIV, the nasal cannulas for HFNO will be placed in the patient's nares then the laryngoscopy will be performed.
Control group: The control group will receive usual care, i.e., no oxygen during the apneic phase (between the laryngoscopy and the success of the intubation procedure) During the preoxygenation and hypoventilation phase until laryngoscopy, NIV alone will be used as in the experimental group.
Read the detailed description
Endotracheal intubation is often performed in intensive care unit (ICU). Severe complications (such as severe hypoxemia, hypotension, cardiac arrest) occur up to 50%. Severe hypoxemia is more frequent in patients with hypoxemia prior to intubation or during difficult intubation and could increase the risk of cardiac arrest.
The procedure of intubation includes, in order 1) a preoxygenation phase ending with iv administration of anesthetic drugs 2) a hypoventilation phase 3) an apneic phase beginning with laryngoscopy and ending with successful intubation 4) mechanical ventilation. Optimization of this procedure is essential.
Non-invasive ventilation (NIV) is recommended for preoxygenation in hypoxemic patients and this technique can maintain ventilation during the hypoventilation phase.
Apneic oxygenation is defined as the administration of oxygen during the apneic phase. The objective is to increase the duration of apnea without desaturation. In physiological studies and in the operating room, when apneic oxygen is used with standard oxygen (up to 15L/min) or high-flow nasal oxygenation (HFNO) (up to 70L/min and FiO2 at 1.0), the apnea length without desaturation can reach several minutes.
Several meta-analyses (with high heterogeneity between studies) found that apneic oxygenation (including standard oxygen or HFNO) in emergency intubation could decrease the risk of hypoxemia. In most studies that investigated the effect of HFNO as apneic oxygenation, HFNO was also used as a preoxygenation method. Thus, the different methods of preoxygenation could affect the real effect of apneic oxygenation.
Only one single-center study evaluated apneic oxygenation with HFNO after preoxygenation by NIV. In this study the lowest SpO2 during intubation procedure was significantly higher in the apneic oxygenation group. However, in this study the mask used for NIV was applied over the nasal cannulas of HFNO, which may have resulted in less efficient preoxygenation due to leakage.
Intubation rate for HFNO failure during acute respiratory failure is about 40% in ICU patients. The question of continuing HFNO or not during the apnea phase remains open. The experts suggest continuing HFNO during intubation (conditional recommendation, moderate certainty).
We hypothesized that apneic oxygenation (between the laryngoscopy and the success of intubation) with HFNO compared to no apneic oxygenation could decrease the risk of severe hypoxemia after intubation in hypoxemic critical ill patients.
In both groups, NIV will be used during the preoxygenation and hypoventilation phases.
Procedure of intubation will be standardized according to guidelines
- Preoxygenation will be performed using NIV through a facemask in both group
- Experimental group: The nasal cannulas of HFNO will be placed on hold beneath the patient's chin (with HFNO on and set with a flow at 60-70L.min-1, FiO2 1.0) pending laryngoscopy began.
- Control group: no HFNO
- Rapide sequence induction (etomidate or ketamine + succinylcholine or rocuronium)
- Hypoventilation phase will be continue in both groupe for 1min using NIV through a facemask
- At the time of laryngoscopy :
- Experimental group: after removing the facemask of NIV, the nasal cannulas for HFNO will be placed in the patient's nares then the laryngoscopy will be performed.
- Control group: After removing the facemask, laryngoscopy will be performed without oxygen.
- recommandation of using a videolaryngoscope with a bougie or stylet
- Use of capnography to confirm the success of procedure
- initiate or increase vasopressors if needed
- Initiation of long-term sedation
- Initiation protective ventilation
- Conditions
- Hypoxemic Acute Respiratory Failure
- Being tested
- Apneic oxygenation, Usual Care
- Keywords
- IUC, Hypoxemic acute respiratory failure, HFNO
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apneic oxygenationProcedure or surgery
- Preoxygenation will be performed using NIV for 3-5 min With nasal cannulas placed in standby beneath the patient's chin (with HFNO on and set with a flow at 60-70L.min-1, FiO2 1.0)
- Rapide sequence induction
- Hypoventilation phase will be continue for 1 min using NIV
- At the time of laryngoscopy :
After removing the facemask, the nasal cannulas of HFNO will be placed in the patient's nares then the laryngoscopy will be performed.
- Use of capnography to confirm the success of procedure
Usual CareProcedure or surgery
- Preoxygenation will be performed using NIV for 3-5 min without HFNO
- Rapide sequence induction
- Hypoventilation phase will be continue using NIV for 1min
- At the time of laryngoscopy :
After removing the facemask, laryngoscopy will be performed without oxygen.
- Use of capnography to confirm the success of procedure
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Apneic oxygenation will be used with HFNO between the laryngoscopy and the successful intubation (study intervention).
NIV alone will be used for the preoxygenation and hypoventilation phase until the laryngoscopy.
Apneic oxygenation will be used with HFNO at the time of laryngoscopy after removing the facemask of NIV (with HFNO on and set with a flow at 60-70L.min-1, FiO2 1.0) Receives: Procedure: Apneic oxygenation |
| Control group | Other | The control group will receive usual care, i.e., no oxygen during the apneic phase (between the laryngoscopy and the success of the intubation procedure) During the preoxygenation and hypoventilation phase until laryngoscopy, NIV alone will be used as in the experimental group. Receives: Procedure: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe hypoxemia
The incidence of severe hypoxemia defined as the occurrence of at least one episode of oxygen saturation measured by pulse oximetry (SpO2) < 80%
Measured: from the start of laryngoscopy to 5 minutes after successful intubation
Secondary outcomes (7)
Incidence of prolonged severe hypoxemia
The incidence of prolonged severe hypoxemia defined by an SpO2 < 80% for more than 24 seconds
Measured: from the start of laryngoscopy to 5 minutes after successful intubation
The highest and lowest SpO2 values during the procedure
The highest and lowest SpO2 values during the procedure
Measured: from the start of laryngoscopy to 5 minutes after successful intubation
The occurrence of each immediate severe complications
The occurrence of each immediate severe complications including cardiovascular instability (systolic arterial blood pressure <65 mmHg at least once, new or increase need of vasopressors or fluid bolus >15 mL/kg), cardiac arrest, new onset cardiac arrhythmia (atrial fibrillation, ventricular tachycardia, bradycardia <30beats per minute).
Measured: from the start of laryngoscopy to 5 minutes after successful intubation
The occurrence of each other adverse events
The occurrence of each other adverse events: difficult intubation (defined as a procedure requiring more than 2 laryngoscopy attempts before success), operator-reported aspiration between induction and intubation, dental injury, esophageal intubation, pneumothorax visualized on the follow-up chest X-ray as part of the patient's routine care.
Measured: from the start of laryngoscopy to 5 minutes after successful intubation; At Day 28
Duration of laryngoscopy
The duration of laryngoscopy will be compared in both group
Measured: From the 1st attempt to the successful intubation
Number of laryngoscopies
The number of laryngoscopies will be compared in both group
Measured: from the 1st attempt to the successful intubation
Day-28 mortality
Measured: at Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start30 Oct 2025 (estimated)
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxemic Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189338
- Sponsor's protocol ID
- DR240020
- Acronym
- APNEIC
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apneic Oxygenation With High-flow Nasal Oxygenation After Preoxygenation With Noninvasive Ventilation Before Intubation in Hypoxemic Patients in Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT07189338
- Acronym / sponsor ID
- APNEIC / DR240020
- Conditions
- Hypoxemic Acute Respiratory Failure
- Keywords
- IUC, Hypoxemic acute respiratory failure, HFNO
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 30 Oct 2025 (estimated)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this clinical study is to assess whether apneic oxygenation with High-Flow Nasal Oxygen (HFNO) would decrease the incidence of severe hypoxemia compared to no apneic oxygenation during the intubation procedure (from the start of laryngoscopy to 5 minutes after successful intubation) in patients with hypoxemic acute respiratory failure.
The sponsor expects that apneic oxygenation (between the laryngoscopy and the success of intubation) with HFNO compared to no apneic oxygenation could decrease the risk of severe hypoxemia after intubation in hypoxemic critical ill patients.
Participants will be enrolled according to eligibility criteria and randomized into one of the following groups:
Experimental group : Apneic oxygenation will be used with HFNO between the laryngoscopy and the successful intubation (study intervention).
non-invasive ventilation (NIV) alone will be used for the preoxygenation and hypoventilation phase until the laryngoscopy. The nasal cannulas of HFNO will be placed on hold beneath the patient's chin (with HFNO on and set with a flow at 60-70L.min-1, FiO2 1.0) pending laryngoscopy began.
At the time of laryngoscopy: after removing the facemask of NIV, the nasal cannulas for HFNO will be placed in the patient's nares then the laryngoscopy will be performed.
Control group: The control group will receive usual care, i.e., no oxygen during the apneic phase (between the laryngoscopy and the success of the intubation procedure) During the preoxygenation and hypoventilation phase until laryngoscopy, NIV alone will be used as in the experimental group.
Detailed description
Endotracheal intubation is often performed in intensive care unit (ICU). Severe complications (such as severe hypoxemia, hypotension, cardiac arrest) occur up to 50%. Severe hypoxemia is more frequent in patients with hypoxemia prior to intubation or during difficult intubation and could increase the risk of cardiac arrest.
The procedure of intubation includes, in order 1) a preoxygenation phase ending with iv administration of anesthetic drugs 2) a hypoventilation phase 3) an apneic phase beginning with laryngoscopy and ending with successful intubation 4) mechanical ventilation. Optimization of this procedure is essential.
Non-invasive ventilation (NIV) is recommended for preoxygenation in hypoxemic patients and this technique can maintain ventilation during the hypoventilation phase.
Apneic oxygenation is defined as the administration of oxygen during the apneic phase. The objective is to increase the duration of apnea without desaturation. In physiological studies and in the operating room, when apneic oxygen is used with standard oxygen (up to 15L/min) or high-flow nasal oxygenation (HFNO) (up to 70L/min and FiO2 at 1.0), the apnea length without desaturation can reach several minutes.
Several meta-analyses (with high heterogeneity between studies) found that apneic oxygenation (including standard oxygen or HFNO) in emergency intubation could decrease the risk of hypoxemia. In most studies that investigated the effect of HFNO as apneic oxygenation, HFNO was also used as a preoxygenation method. Thus, the different methods of preoxygenation could affect the real effect of apneic oxygenation.
Only one single-center study evaluated apneic oxygenation with HFNO after preoxygenation by NIV. In this study the lowest SpO2 during intubation procedure was significantly higher in the apneic oxygenation group. However, in this study the mask used for NIV was applied over the nasal cannulas of HFNO, which may have resulted in less efficient preoxygenation due to leakage.
Intubation rate for HFNO failure during acute respiratory failure is about 40% in ICU patients. The question of continuing HFNO or not during the apnea phase remains open. The experts suggest continuing HFNO during intubation (conditional recommendation, moderate certainty).
We hypothesized that apneic oxygenation (between the laryngoscopy and the success of intubation) with HFNO compared to no apneic oxygenation could decrease the risk of severe hypoxemia after intubation in hypoxemic critical ill patients.
In both groups, NIV will be used during the preoxygenation and hypoventilation phases.
Procedure of intubation will be standardized according to guidelines
- Preoxygenation will be performed using NIV through a facemask in both group
- Experimental group: The nasal cannulas of HFNO will be placed on hold beneath the patient's chin (with HFNO on and set with a flow at 60-70L.min-1, FiO2 1.0) pending laryngoscopy began.
- Control group: no HFNO
- Rapide sequence induction (etomidate or ketamine + succinylcholine or rocuronium)
- Hypoventilation phase will be continue in both groupe for 1min using NIV through a facemask
- At the time of laryngoscopy :
- Experimental group: after removing the facemask of NIV, the nasal cannulas for HFNO will be placed in the patient's nares then the laryngoscopy will be performed.
- Control group: After removing the facemask, laryngoscopy will be performed without oxygen.
- recommandation of using a videolaryngoscope with a bougie or stylet
- Use of capnography to confirm the success of procedure
- initiate or increase vasopressors if needed
- Initiation of long-term sedation
- Initiation protective ventilation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Apneic oxygenationApneic oxygenation will be used with HFNO between the laryngoscopy and the successful intubation (study intervention). NIV alone will be used for the preoxygenation and hypoventilation phase until the laryngoscopy. Apneic oxygenation will be used with HFNO at the time of laryngoscopy after removing the facemask of NIV (with HFNO on and set with a flow at 60-70L.min-1, FiO2 1.0) |
| Control group | Other | Procedure: Usual CareThe control group will receive usual care, i.e., no oxygen during the apneic phase (between the laryngoscopy and the success of the intubation procedure) During the preoxygenation and hypoventilation phase until laryngoscopy, NIV alone will be used as in the experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient admitted in the ICU
- Indication of orotracheal intubation for Hypoxemic acute respiratory failure defined by:
- Informed consent from the patient or relatives. An emergency procedure will be possible when necessary.
Key exclusion criteria (8 listed)
- < 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apneic oxygenation* Preoxygenation will be performed using NIV for 3-5 min With nasal cannulas placed in standby beneath the patient's chin (with HFNO on and set with a flow at 60-70L.min-1, FiO2 1.0) * Rapide sequence induction * Hypoventilation phase will be continue for 1 min using NIV * At the time of laryngoscopy : After removing the facemask, the nasal cannulas of HFNO will be placed in the patient's nares then the laryngoscopy will be performed. * Use of capnography to confirm the success of procedure | Procedure or surgery | Experimental group |
| Usual Care* Preoxygenation will be performed using NIV for 3-5 min without HFNO * Rapide sequence induction * Hypoventilation phase will be continue using NIV for 1min * At the time of laryngoscopy : After removing the facemask, laryngoscopy will be performed without oxygen. * Use of capnography to confirm the success of procedure | Procedure or surgery | Control group |
Primary outcome
Incidence of severe hypoxemia
Time frame: from the start of laryngoscopy to 5 minutes after successful intubation
The incidence of severe hypoxemia defined as the occurrence of at least one episode of oxygen saturation measured by pulse oximetry (SpO2) < 80%
7 secondary outcomes
Incidence of prolonged severe hypoxemia
Time frame: from the start of laryngoscopy to 5 minutes after successful intubation
The highest and lowest SpO2 values during the procedure
Time frame: from the start of laryngoscopy to 5 minutes after successful intubation
The occurrence of each immediate severe complications
Time frame: from the start of laryngoscopy to 5 minutes after successful intubation
The occurrence of each other adverse events
Time frame: from the start of laryngoscopy to 5 minutes after successful intubation; At Day 28
Duration of laryngoscopy
Time frame: From the 1st attempt to the successful intubation
Number of laryngoscopies
Time frame: from the 1st attempt to the successful intubation
Day-28 mortality
Time frame: at Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apneic oxygenation in people with Hypoxemic Acute Respiratory Failure, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mai-Anh Nay, MD (+33 2 38 57 52 53, mainah.nay@chu-orleans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of severe hypoxemia (time frame: from the start of laryngoscopy to 5 minutes after successful intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.