Effects of Nasal Ventilation on Cerebral and Pulmonary Function in Orally Intubated Patients (VENTINA)

December 2, 2025 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75013
        • Recruiting
        • Service de Médecine Intensive Réanimation - Hôpital Pitié -Salpêtrière
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. Age ≥ 18 years old
  2. Hypoxemic acute respiratory failure
  3. Intubation and mechanical ventilation since less than 4 days
  4. PaO2/FiO2 ratio less than 200
  5. RASS<-4
  6. Consent obtained from next of kin
  7. Patient with health insurance

Exclusion Criteria:

  1. Central nervous system diseases (stroke, MS, epilepsy)
  2. Psychiatric illnesses (psychosis, depression) (indicated on patient's medical record)
  3. Hemodynamic instability (noradrenalin>2mg/h)
  4. Patient on AME
  5. Patients under legal protection (guardianship/curators)
  6. Pregnant or breast-feeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: EEG activity measurement

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.

Other Names:
  • Post-intubation nasal ventilation
  • Additional blood samples (from care catheter 1.5 mL)
  • Electrical impedance tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At inclusion (day 1) - step 1 to 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study the effects of nasal ventilation on cerebral perfusion
Time Frame: At inclusion (day 1) - step 1 to 6
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)
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
Cerebral tissue oxygenation (% of O2) measured by NIRS (Near Infrared Spectroscopy) electrodes
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
Ratio of PaO2 (partial pressure of O2) /FiO2 (inspired oxygen fraction)
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
Evaluation of PaCO2 (partial pressure of CO2) (mmHG)
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
Evaluation of impedance variation by thoracic electrical impedance tomography.
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
Evaluation of ventilation homogeneity by I thoracic electrical impedance tomography.
At inclusion (day 1) - step 1 to 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

May 21, 2024

First Submitted That Met QC Criteria

May 29, 2024

First Posted (Actual)

May 31, 2024

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP240271

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe