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Clinical Trials in France / NCT06438302
Recruiting Observational

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

NCT06438302 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-01-31
Last updated
2025-12-03

Condition(s) studied

Hypoxemic Acute Respiratory Failure

Investigational drug(s) / intervention(s)

EEG activity measurement

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.

Study 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. 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Service de Médecine Intensive Réanimation - Hôpital Pitié -Salpêtrière Paris France Recruiting

More Assistance Publique - Hôpitaux de Paris trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06438302 on ClinicalTrials.gov ↗ ← All trials in France