Hypoxemic Acute Respiratory FailureVENTINANCT06438302
Effects of Nasal Ventilation on Cerebral and Pulmonary Function in Orally Intubated Patients
An observational study of Hypoxemic Acute Respiratory Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The passage of air through the nasal cavity generates rhythmic oscillations transmitted by the olfactory bulb to the brain, which induces cerebral activation in functional areas and is associated with better cognitive performance compared to oral breathing. 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?
- EEG activity measurement
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2025to 1 Feb 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: The study population will be adult patients with acute respiratory failure who are orally intubated and sedated. These patients should be free of neurological and psychiatric diseases prior to ICU admission. The choice of this particular population is justified by its exposure to mechanical ventilation and continuous sedation, which are recognized risk factors for brain damage.
Who may be able to join
- Age ≥ 18 years old
- Hypoxemic acute respiratory failure
- Intubation and mechanical ventilation since less than 4 days
- PaO2/FiO2 ratio less than 200
- RASS<-4
- Consent obtained from next of kin
- Patient with health insurance
Who cannot join
- Central nervous system diseases (stroke, MS, epilepsy)
- Psychiatric illnesses (psychosis, depression) (indicated on patient's medical record)
- Hemodynamic instability (noradrenalin>2mg/h)
- Patient on AME
- Patients under legal protection (guardianship/curators)
- Pregnant or breast-feeding women
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, 1 recruiting
- Recruiting
Service de Médecine Intensive Réanimation - Hôpital Pitié -Salpêtrière
Paris, 75013
Martin DRES, Pr, 0142167809 ext. +33, martin.dres@aphp.fr
About this study
The passage of air through the nasal cavity generates rhythmic oscillations transmitted by the olfactory bulb to the brain, which induces cerebral activation in functional areas and is associated with better cognitive performance compared to oral breathing. Consequently, the abolition of nasal ventilation in patients intubated via the orotracheal route could have deleterious effects on brain activity. Besides the loss of olfaction, the abolition of nasal ventilation could affect brain activity and respiratory control, consequently altering regional pulmonary ventilation.
The hypothesis of the study is that nasal ventilation through the passage of humidified nasal airflow in patients intubated via the orotracheal route would be associated with modulation of cerebral electrical activity and tissue oxygenation and a modification of regional pulmonary ventilation.
Read the detailed description
The effects of nasal ventilation on cerebral activity will be studied on orally intubated and sedated patients in six experimental conditions. The first condition consists of nociceptive stimulation of the left upper limb as a negative control. In three conditions, the inspired fraction of oxygen (FiO2) will remain at 21% while applying three different rates of humidified nasal air at 0L/min, 30L/min and 60L/min respectively. The last two conditions consist of applying humidified nasal air at 30L/min and 60L/min with a FiO2 of 100%. The primary objective of this study is to evaluate the effects of high-flow humidified nasal air on electroencephalogram activity (root mean square gamma frequency) in sedated, orally intubated patients. The secondary objectives of the study are to evaluate the effects of high-flow humidified nasal air on cerebral perfusion and oxygenation, gas exchange and regional pulmonary ventilation in the same patients.
- Conditions
- Hypoxemic Acute Respiratory Failure
- Being tested
- EEG activity measurement
- Keywords
- nasal ventilation, orotracheal intubation, brain activity
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG activity measurementDevice
Also called Post-intubation nasal ventilation, Additional blood samples (from care catheter 1.5 mL), Electrical impedance tomography
The nasal ventilation device (placed as part of the research) (AIRVO 2; Fisher and Paykel Healthcare, Auckland, New Zealand) will be positioned via nasal cannulas adapted to the patient's anatomy. The FiO2 will be set at 21% and the flow rate will be fixed at 0 L/min at the inclusion visit. The temperature of the humidified nasal oxygenator will be set at 31°C.
Six 30-minute experimental conditions will be performed successively: 1) 0 L/min flow, FiO2 21%, 2) 30 L/min flow, FiO2 21%, 3) 30 L/min flow, FiO2 100%, 4) 60 L/min flow, FiO2 21%, 5) 60 L/min flow, FiO2 100%, 6) Negative control.
At the end of each condition, a 10-minute thoracic electrical impedance tomography recording, a 10-minute EEG recording, a 10-minute cerebral NIRS recording and an instantaneous temporal Doppler velocity measurement will be performed. A blood gas (1.5 mL) will also be taken at the end of each condition.
| Study group | Role | What they receive |
|---|---|---|
| Major mechanically ventilated patients intubated orotracheally | The study population will be adult patients with acute respiratory failure who are orally intubated and sedated. These patients should be free of neurological and psychiatric diseases prior to ICU admission. The choice of this particular population is justified by its exposure to mechanical ventilation and continuous sedation, which are recognized risk factors for brain damage. Receives: Device: EEG activity measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the effects of nasal ventilation on brain electrical activity using electroencephalogram recording (EEG) in sedated orotracheally intubated patients.
EEG spectral density spectrum of gamma frequency.
Measured: At inclusion (day 1) - step 1 to 6
Secondary outcomes (6)
Study the effects of nasal ventilation on cerebral perfusion
This outcome will be assessed by the evaluation of the Index of Pulsatility (IP) (IP=(Vs-Vd)/Vm: Vs: Systolic velocity; Vd: Diastolic Velocity; Vm: Mean Velocity)
Measured: At inclusion (day 1) - step 1 to 6
Study the effects of nasal ventilation on cerebral tissue oxygenation
Cerebral tissue oxygenation (% of O2) measured by NIRS (Near Infrared Spectroscopy) electrodes
Measured: At inclusion (day 1) - step 1 to 6
Study the effects of nasal ventilation on gas exchange
Ratio of PaO2 (partial pressure of O2) /FiO2 (inspired oxygen fraction)
Measured: At inclusion (day 1) - step 1 to 6
Study the effects of nasal ventilation on gas exchange
Evaluation of PaCO2 (partial pressure of CO2) (mmHG)
Measured: At inclusion (day 1) - step 1 to 6
Study the effects of nasal ventilation on regional lung ventilation distribution
Evaluation of impedance variation by thoracic electrical impedance tomography.
Measured: At inclusion (day 1) - step 1 to 6
Study the effects of nasal ventilation on regional lung ventilation distribution
Evaluation of ventilation homogeneity by I thoracic electrical impedance tomography.
Measured: At inclusion (day 1) - step 1 to 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start31 Jan 2025
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 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 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
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438302
- Sponsor's protocol ID
- APHP240271
- Acronym
- VENTINA
- Status last verified
- Dec 2025
- First submitted
- 21 May 2024
- Last updated
- 3 Dec 2025
- 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 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nasal Ventilation on Cerebral and Pulmonary Function in Orally Intubated Patients
- ClinicalTrials.gov ID
- NCT06438302
- Acronym / sponsor ID
- VENTINA / APHP240271
- Conditions
- Hypoxemic Acute Respiratory Failure
- Keywords
- nasal ventilation, orotracheal intubation, brain activity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 31 May 2024 (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 passage of air through the nasal cavity generates rhythmic oscillations transmitted by the olfactory bulb to the brain, which induces cerebral activation in functional areas and is associated with better cognitive performance compared to oral breathing. Consequently, the abolition of nasal ventilation in patients intubated via the orotracheal route could have deleterious effects on brain activity. Besides the loss of olfaction, the abolition of nasal ventilation could affect brain activity and respiratory control, consequently altering regional pulmonary ventilation.
The hypothesis of the study is that nasal ventilation through the passage of humidified nasal airflow in patients intubated via the orotracheal route would be associated with modulation of cerebral electrical activity and tissue oxygenation and a modification of regional pulmonary ventilation.
Detailed description
The effects of nasal ventilation on cerebral activity will be studied on orally intubated and sedated patients in six experimental conditions. The first condition consists of nociceptive stimulation of the left upper limb as a negative control. In three conditions, the inspired fraction of oxygen (FiO2) will remain at 21% while applying three different rates of humidified nasal air at 0L/min, 30L/min and 60L/min respectively. The last two conditions consist of applying humidified nasal air at 30L/min and 60L/min with a FiO2 of 100%. The primary objective of this study is to evaluate the effects of high-flow humidified nasal air on electroencephalogram activity (root mean square gamma frequency) in sedated, orally intubated patients. The secondary objectives of the study are to evaluate the effects of high-flow humidified nasal air on cerebral perfusion and oxygenation, gas exchange and regional pulmonary ventilation in the same patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Major mechanically ventilated patients intubated orotracheally | – | Device: EEG activity measurementThe study population will be adult patients with acute respiratory failure who are orally intubated and sedated. These patients should be free of neurological and psychiatric diseases prior to ICU admission. The choice of this particular population is justified by its exposure to mechanical ventilation and continuous sedation, which are recognized risk factors for brain damage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be adult patients with acute respiratory failure who are orally intubated and sedated. These patients should be free of neurological and psychiatric diseases prior to ICU admission. The choice of this particular population is justified by its exposure to mechanical ventilation and continuous sedation, which are recognized risk factors for brain damage.
Key inclusion criteria (7 listed)
- Age ≥ 18 years old
- Hypoxemic acute respiratory failure
- Intubation and mechanical ventilation since less than 4 days
- PaO2/FiO2 ratio less than 200
- RASS<-4
Key exclusion criteria (6 listed)
- Central nervous system diseases (stroke, MS, epilepsy)
- Psychiatric illnesses (psychosis, depression) (indicated on patient's medical record)
- Hemodynamic instability (noradrenalin>2mg/h)
- Patient on AME
- Patients under legal protection (guardianship/curators)
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 activity measurementAlso: Post-intubation nasal ventilation, Additional blood samples (from care catheter 1.5 mL), Electrical impedance tomographyThe nasal ventilation device (placed as part of the research) (AIRVO 2; Fisher and Paykel Healthcare, Auckland, New Zealand) will be positioned via nasal cannulas adapted to the patient's anatomy. The FiO2 will be set at 21% and the flow rate will be fixed at 0 L/min at the inclusion visit. The temperature of the humidified nasal oxygenator will be set at 31°C. Six 30-minute experimental conditions will be performed successively: 1) 0 L/min flow, FiO2 21%, 2) 30 L/min flow, FiO2 21%, 3) 30 L/min flow, FiO2 100%, 4) 60 L/min flow, FiO2 21%, 5) 60 L/min flow, FiO2 100%, 6) Negative control. At the end of each condition, a 10-minute thoracic electrical impedance tomography recording, a 10-minute EEG recording, a 10-minute cerebral NIRS recording and an instantaneous temporal Doppler velocity measurement will be performed. A blood gas (1.5 mL) will also be taken at the end of each condition. | Device | Major mechanically ventilated patients intubated orotracheally |
Primary outcome
Study the effects of nasal ventilation on brain electrical activity using electroencephalogram recording (EEG) in sedated orotracheally intubated patients.
Time frame: At inclusion (day 1) - step 1 to 6
EEG spectral density spectrum of gamma frequency.
6 secondary outcomes
Study the effects of nasal ventilation on cerebral perfusion
Time frame: At inclusion (day 1) - step 1 to 6
Study the effects of nasal ventilation on cerebral tissue oxygenation
Time frame: At inclusion (day 1) - step 1 to 6
Study the effects of nasal ventilation on gas exchange
Time frame: At inclusion (day 1) - step 1 to 6
Study the effects of nasal ventilation on gas exchange
Time frame: At inclusion (day 1) - step 1 to 6
Study the effects of nasal ventilation on regional lung ventilation distribution
Time frame: At inclusion (day 1) - step 1 to 6
Study the effects of nasal ventilation on regional lung ventilation distribution
Time frame: At inclusion (day 1) - step 1 to 6
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 3 Dec 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxemic Acute Respiratory Failure, run by Assistance Publique - Hôpitaux de Paris 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 7 inclusion and 6 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 3 Dec 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 Martin Dres (0142167809, martin.dres@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study the effects of nasal ventilation on brain electrical activity using electroencephalogram recording (EEG) in sedated orotracheally intubated patients. (time frame: At inclusion (day 1) - step 1 to 6). 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 3 Dec 2025.