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NCT Number: NCT06438302

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

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.

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Key information

Conditions

Hypoxemic Acute Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Médecine Intensive Réanimation - Hôpital Pitié -Salpêtrière

Paris, 75013, France

Location status: Recruiting

Location contact

Martin DRES, Pr

CONTACT

[email protected]

0142167809 ext. +33

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

EEG activity measurement

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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

  3. 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)

  4. 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)

  5. 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.

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Dres

CONTACT

[email protected]

0142167809

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: VENTINA

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 31, 2024
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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