Acute Respiratory FailureBrainFlowNCT07279831
Brain-lung Interaction During Acute Respiratory Failure
An observational study of Acute Respiratory Failure, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
Acute hypoxemic de novo respiratory failure (AHRF) is a common cause of admission to the intensive care unit (ICU). Its main cause is community-acquired pneumonia. Prevention of intubation relies, among other things, on high-flow nasal canulae (HFNC). However, approximately 40% of patients are intubated despite HFNC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- EEG/NIRS/EMG
- How many people
- 25 participants
- Where
- 2 sitesFrance
- Study dates
- 22 Apr 2026to 29 Jan 2028
- Phase
- Observational
- 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
Study population: Adult patients admitted to critical care for acute renal failure
Who may be able to join
- - Age ≥ 18 years
- Admitted to the intensive care within the last 48 hours
- De novo acute hypoxemic respiratory failure with an indication for high-flow nasal cannula (HFNC), defined by the combination of the following three criteria:
- Tachypnea > 25 breaths/min or labored breathing
- PaO2 (partial pressure of oxygen ) /FiO2 ( fraction of inspired oxygen ) ≤ 200 mmHg
- Unilateral or bilateral alveolar opacities on chest X-ray
- Decision by the attending physician to initiate HFNC treatment
- After information, the patient or next of kind did not refuse to participate (according to the French law, written informed consent is waived)
Who cannot join
- - Exacerbation of an underlying chronic respiratory disease
- Acute cardiogenic pulmonary edema indicating non-invasive ventilation (NIV)
- Hypercapnia > 45 mmHg indicating NIV
- Glasgow Coma Scale < 13
- Imminent intubation
- Underlying central neurological disease likely to alter EEG signals
Show all 9Show fewer
- Pregnancy or breastfeeding
- Lack of health insurance coverage
- Patient under legal protection
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Médecine Intensive - Réanimation, Hôpital Pitié Salpêtrière
Paris, 75013
Alexandre DEMOULE, Pr, 0142167761, alexandre.demoule@aphp.fr
- Not yet recruiting
Service de Médecine Intensive et Réanimation, Hôpital Pitié Salpêtrière
Paris
Alexandre Demoule, 0142167888, alexandre.demoule@aphp.fr
Martin Dres, 0142167965, martin.dres@aphp.fr
About this study
Official title: Brain-lung Interactions in Patients Receiving High-flow Humidified Oxygen for de Novo Acute Hypoxemic Respiratory Failure
Acute hypoxemic de novo respiratory failure (AHRF) is a common cause of admission to the intensive care unit (ICU). Its main cause is community-acquired pneumonia. Prevention of intubation relies, among other things, on high-flow nasal canulae (HFNC). However, approximately 40% of patients are intubated despite HFNC.
Our team has developed measurements derived from electroencephalograms (EEG) and near-infrared spectroscopy (NIRS) that enable the study of brain-ventilation interactions. To date, these tools have been studied exclusively in intubated patients. the investigators now wish to study them in non-intubated patients.
Read more
The objective of this study is to investigate the relationship between the brain and lungs in adult patients admitted to the intensive care unit for acute hypoxemic respiratory failure and for whom the attending physician has decided to initiate HFNC.
Before and one hour after the introduction of HFNC, electroencephalogram (EEG), near-infrared spectroscopy (NIRS), and electromyogram (EMG) of the Scalen muscles will be collected.
From these recordings, the following variables will be collected: 1) The density of the gamma (30-100 Hz), beta (13-30 Hz), alpha (8-12 Hz), theta (4-8 Hz), and delta (0.5-4 Hz) frequency spectrum of the EEG in each of the following right and left cortical regions: medial region of the prefrontal cortex, anterior region of the cingulate gyrus, posterior region of the cingulate gyrus, insula, somatosensory cortex, angular gyrus, lateral prefrontal cortex, and supplementary motor area; 2) Connectivity between these regions for each frequency spectrum; 3) Pre-inspiratory potential; 4) Rieman classifier; 5) Coherence and Granger causality between each frequency spectrum and the scalene muscles EMG.
These variables will be compared before and 1 hour after initiation of HFNC and between patients who will be intubated because of HFNC failure and those who will not.
Read the detailed description
Acute hypoxemic de novo respiratory failure (AHRF) is a common cause of admission to the intensive care unit (ICU). Its main cause is community-acquired pneumonia. Prevention of intubation relies, among other things, on high-flow nasal canulae (HFNC). However, approximately 40% of patients are intubated despite HFNC.
Our team has developed measurements derived from electroencephalograms (EEG) and near-infrared spectroscopy (NIRS) that enable the study of brain-ventilation interactions. To date, these tools have been studied exclusively in intubated patients. the investigators now wish to study them in non-intubated patients.
The objective of this study is to investigate the relationship between the brain and lungs in adult patients admitted to the intensive care unit for acute hypoxemic respiratory failure and for whom the attending physician has decided to initiate HFNC.
Before and one hour after the introduction of HFNC, electroencephalogram (EEG), near-infrared spectroscopy (NIRS), and electromyogram (EMG) of the Scalen muscles will be collected.
From these recordings, the following variables will be collected: 1) The density of the gamma (30-100 Hz), beta (13-30 Hz), alpha (8-12 Hz), theta (4-8 Hz), and delta (0.5-4 Hz) frequency spectrum of the EEG in each of the following right and left cortical regions: medial region of the prefrontal cortex, anterior region of the cingulate gyrus, posterior region of the cingulate gyrus, insula, somatosensory cortex, angular gyrus, lateral prefrontal cortex, and supplementary motor area; 2) Connectivity between these regions for each frequency spectrum; 3) Pre-inspiratory potential; 4) Rieman classifier; 5) Coherence and Granger causality between each frequency spectrum and the scalene muscles EMG.
These variables will be compared before and 1 hour after initiation of HFNC and between patients who will be intubated because of HFNC failure and those who will not.
- Conditions
- Acute Respiratory Failure
- Being tested
- EEG/NIRS/EMG
- Keywords
- Acute respiratory failure, High flow nasal cannulae, Electroencephalogram, Near infrared spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG/NIRS/EMGDiagnostic test
Two 10-minute recordings will be made. Each recording will include continuous collection of EEG, NIRS, and EMG data from the scalene muscles, as well as collection of intensive care monitoring variables every minute.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients admitted to critical care for acute renal failure | Not described Receives: Diagnostic Test: EEG/NIRS/EMG |
What is being measured
The primary outcome is the main question the study is designed to answer.
density of the gamma frequency spectrum of the EEG in the medial region of the right prefrontal cerebral cortex
density of the gamma frequency spectrum (30 - 100 Hz) of the EEG in the medial region of the right prefrontal cerebral cortex, before initiation of HFO ( = high-flow oxygen), then 1 hour after its initiation
Measured: before and 1 hour after initiation of high flow nasal cannulae
Secondary outcomes (7)
The density of the gamma, beta, alpha, theta, and delta frequency spectrum
The density of the gamma frequency spectrum (30-100 Hz) of the EEG in the following cortical regions: medial region of the left prefrontal cortex, anterior region of the right and left cingulate gyrus, posterior region of the right and left cingulate gyrus, right and left insula, right and left somatosensory cortex, right and left angular gyrus, right and left lateral prefrontal cortex, and right and left supplementary motor area. and the densities of the beta (13-30 Hz), alpha (8-12 Hz), theta (4-8 Hz), and delta (0.5-4 Hz) frequency spectra in each of the aforementioned right and left cortical regions.
Measured: before and 1 hour after initiation of high flow nasal cannulae
Connectivity
Connectivity between the medial region of the prefrontal cerebral cortex, the anterior region of the cingulate gyrus, the posterior region of the cingulate gyrus, the insula, the medial region of the prefrontal cortex, the somatosensory cortex, the angular gyrus, the lateral prefrontal cortex and the supplementary motor area, right and left, for the gamma (30-100 Hz), beta (13-30 Hz), right and left, alpha (8-12 Hz), right and left, theta (4-8 Hz) and delta (0.5-4 Hz), right and left frequency spectra.
Measured: before and 1 hour after initiation of high flow nasal cannulae
pre-inspiratory potential
the presence of a pre-inspiratory potential will be searched for
Measured: before and 1 hour after initiation of high flow nasal cannulae
Riemann classifier
The area under the curve of the receiver operating characteristics (ROC) of the Riemann classifier will be measured.
Measured: before and 1 hour after initiation of high flow nasal cannulae
Coherence and Granger Causality
The coherence between the EMG and the EEG frequency bands gamma (30-100 Hz), beta (13-30 Hz), right and left, alpha (8-12 Hz), theta (4-8 Hz), and delta (0.5-4 Hz), right and left. If significant coherence exists, the direction of the relationship is determined using Granger causality.
Measured: before and 1 hour after initiation of high flow nasal cannulae
Oxyhemoglobin (HbO2) concentration
Oxyhemoglobin (HbO2) concentration derived from optical densities (fNIRS) using the modified Beer-Lambert law, in the prefrontal and lateral regions of the cortex, right and left.
Measured: before and 1 hour after initiation of high flow nasal cannulae
Change in amplitude for fNIRS frequencies (fNIRS)
The change in amplitude for frequencies (fNIRS) between 1.0 and 1.25 Hz (related to heart rate), between 0.18 and 0.25 Hz (related to respiratory rate), between 0.08 and 0.13 Hz (related to myogenic frequency, sympathetic tone), between 0.05 and 0.07 Hz
Measured: before and 1 hour after initiation of high flow nasal cannulae
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start22 Apr 2026
- Primary completion22 Jan 2028 (estimated)
- Study completion29 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Demoule, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279831
- Sponsor's protocol ID
- APHP251258
- Acronym
- BrainFlow
- Status last verified
- Oct 2026
- First submitted
- 26 Nov 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain-lung Interactions in Patients Receiving High-flow Humidified Oxygen for de Novo Acute Hypoxemic Respiratory Failure
- ClinicalTrials.gov ID
- NCT07279831
- Acronym / sponsor ID
- BrainFlow / APHP251258
- Conditions
- Acute Respiratory Failure
- Keywords
- Acute respiratory failure, High flow nasal cannulae, Electroencephalogram, Near infrared spectroscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- 22 Jan 2028 (estimated)
- Study completion
- 29 Jan 2028 (estimated)
- First posted
- 12 Dec 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.
Acute hypoxemic de novo respiratory failure (AHRF) is a common cause of admission to the intensive care unit (ICU). Its main cause is community-acquired pneumonia. Prevention of intubation relies, among other things, on high-flow nasal canulae (HFNC). However, approximately 40% of patients are intubated despite HFNC.
Our team has developed measurements derived from electroencephalograms (EEG) and near-infrared spectroscopy (NIRS) that enable the study of brain-ventilation interactions. To date, these tools have been studied exclusively in intubated patients. the investigators now wish to study them in non-intubated patients.
The objective of this study is to investigate the relationship between the brain and lungs in adult patients admitted to the intensive care unit for acute hypoxemic respiratory failure and for whom the attending physician has decided to initiate HFNC.
Before and one hour after the introduction of HFNC, electroencephalogram (EEG), near-infrared spectroscopy (NIRS), and electromyogram (EMG) of the Scalen muscles will be collected.
From these recordings, the following variables will be collected: 1) The density of the gamma (30-100 Hz), beta (13-30 Hz), alpha (8-12 Hz), theta (4-8 Hz), and delta (0.5-4 Hz) frequency spectrum of the EEG in each of the following right and left cortical regions: medial region of the prefrontal cortex, anterior region of the cingulate gyrus, posterior region of the cingulate gyrus, insula, somatosensory cortex, angular gyrus, lateral prefrontal cortex, and supplementary motor area; 2) Connectivity between these regions for each frequency spectrum; 3) Pre-inspiratory potential; 4) Rieman classifier; 5) Coherence and Granger causality between each frequency spectrum and the scalene muscles EMG.
These variables will be compared before and 1 hour after initiation of HFNC and between patients who will be intubated because of HFNC failure and those who will not.
Detailed description
Acute hypoxemic de novo respiratory failure (AHRF) is a common cause of admission to the intensive care unit (ICU). Its main cause is community-acquired pneumonia. Prevention of intubation relies, among other things, on high-flow nasal canulae (HFNC). However, approximately 40% of patients are intubated despite HFNC.
Our team has developed measurements derived from electroencephalograms (EEG) and near-infrared spectroscopy (NIRS) that enable the study of brain-ventilation interactions. To date, these tools have been studied exclusively in intubated patients. the investigators now wish to study them in non-intubated patients.
The objective of this study is to investigate the relationship between the brain and lungs in adult patients admitted to the intensive care unit for acute hypoxemic respiratory failure and for whom the attending physician has decided to initiate HFNC.
Before and one hour after the introduction of HFNC, electroencephalogram (EEG), near-infrared spectroscopy (NIRS), and electromyogram (EMG) of the Scalen muscles will be collected.
From these recordings, the following variables will be collected: 1) The density of the gamma (30-100 Hz), beta (13-30 Hz), alpha (8-12 Hz), theta (4-8 Hz), and delta (0.5-4 Hz) frequency spectrum of the EEG in each of the following right and left cortical regions: medial region of the prefrontal cortex, anterior region of the cingulate gyrus, posterior region of the cingulate gyrus, insula, somatosensory cortex, angular gyrus, lateral prefrontal cortex, and supplementary motor area; 2) Connectivity between these regions for each frequency spectrum; 3) Pre-inspiratory potential; 4) Rieman classifier; 5) Coherence and Granger causality between each frequency spectrum and the scalene muscles EMG.
These variables will be compared before and 1 hour after initiation of HFNC and between patients who will be intubated because of HFNC failure and those who will not.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients admitted to critical care for acute renal failure | – | Diagnostic Test: EEG/NIRS/EMG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to critical care for acute renal failure
Key inclusion criteria (8 listed)
- - Age ≥ 18 years
- Admitted to the intensive care within the last 48 hours
- De novo acute hypoxemic respiratory failure with an indication for high-flow nasal cannula (HFNC), defined by the combination of the following three criteria:
- Decision by the attending physician to initiate HFNC treatment
- After information, the patient or next of kind did not refuse to participate (according to the French law, written informed consent is waived)
Key exclusion criteria (9 listed)
- - Exacerbation of an underlying chronic respiratory disease
- Acute cardiogenic pulmonary edema indicating non-invasive ventilation (NIV)
- Hypercapnia > 45 mmHg indicating NIV
- Glasgow Coma Scale < 13
- Imminent intubation
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 |
|---|---|---|
| EEG/NIRS/EMGTwo 10-minute recordings will be made. Each recording will include continuous collection of EEG, NIRS, and EMG data from the scalene muscles, as well as collection of intensive care monitoring variables every minute. | Diagnostic test | Adult patients admitted to critical care for acute renal failure |
Primary outcome
density of the gamma frequency spectrum of the EEG in the medial region of the right prefrontal cerebral cortex
Time frame: before and 1 hour after initiation of high flow nasal cannulae
density of the gamma frequency spectrum (30 - 100 Hz) of the EEG in the medial region of the right prefrontal cerebral cortex, before initiation of HFO ( = high-flow oxygen), then 1 hour after its initiation
7 secondary outcomes
The density of the gamma, beta, alpha, theta, and delta frequency spectrum
Time frame: before and 1 hour after initiation of high flow nasal cannulae
Connectivity
Time frame: before and 1 hour after initiation of high flow nasal cannulae
pre-inspiratory potential
Time frame: before and 1 hour after initiation of high flow nasal cannulae
Riemann classifier
Time frame: before and 1 hour after initiation of high flow nasal cannulae
Coherence and Granger Causality
Time frame: before and 1 hour after initiation of high flow nasal cannulae
Oxyhemoglobin (HbO2) concentration
Time frame: before and 1 hour after initiation of high flow nasal cannulae
Change in amplitude for fNIRS frequencies (fNIRS)
Time frame: before and 1 hour after initiation of high flow nasal cannulae
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 14 Oct 2026.
- Individual participant dataSharing planned: Yes. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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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.
Alexandre Demoule principal investigator
APHP
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure, run by Assistance Publique - Hôpitaux de Paris at 2 sites 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 8 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Alexandre Demoule (0142167888, alexandre.demoule@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
density of the gamma frequency spectrum of the EEG in the medial region of the right prefrontal cerebral cortex (time frame: before and 1 hour after initiation of high flow nasal cannulae). 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 14 Oct 2026.