Clinical trial NCT06438302: Effects of Nasal Ventilation on Cerebral and Pulmonary Function in Orally Intubated Patients
Official title: Effects of Nasal Ventilation on Cerebral and Pulmonary Function in Orally Intubated Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypoxemic Acute Respiratory Failure
Keywords: nasal ventilation
orotracheal intubation
brain activity
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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 outcomes:
measure: Study the effects of nasal ventilation on brain electrical activity using electroencephalogram recording (EEG) in sedated orotracheally intubated patients.
timeFrame: At inclusion (day 1) - step 1 to 6
Secondary outcomes:
measure: Study the effects of nasal ventilation on cerebral perfusion
timeFrame: At inclusion (day 1) - step 1 to 6
measure: Study the effects of nasal ventilation on cerebral tissue oxygenation
timeFrame: At inclusion (day 1) - step 1 to 6
measure: Study the effects of nasal ventilation on gas exchange
timeFrame: At inclusion (day 1) - step 1 to 6
measure: Study the effects of nasal ventilation on gas exchange
timeFrame: At inclusion (day 1) - step 1 to 6
measure: Study the effects of nasal ventilation on regional lung ventilation distribution
timeFrame: At inclusion (day 1) - step 1 to 6
measure: Study the effects of nasal ventilation on regional lung ventilation distribution
timeFrame: At inclusion (day 1) - step 1 to 6
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Médecine Intensive Réanimation - Hôpital Pitié -Salpêtrière
Study officials:
References: