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

Recruiting

• Conditions: Hypoxemic Acute Respiratory Failure

• Registration Number: NCT06438302
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2024-05-21
• Study First Submitted QC: 2024-05-29
• Study First Posted: 2024-05-31
• Status Verified: 2025-01
• Study Start: 2025-01-31
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06
• Primary Completion: 2026-01-31
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study the effects of nasal ventilation on brain electrical activity using electroencephalogram recording (EEG) in sedated orotracheally intubated patients.	At inclusion (day 1) - step 1 to 6	EEG spectral density spectrum of gamma frequency.

Secondary Outcome Measures

Name	Time	Method
Study the effects of nasal ventilation on gas exchange	At inclusion (day 1) - step 1 to 6	Evaluation of PaCO2 (partial pressure of CO2) (mmHG)
Study the effects of nasal ventilation on cerebral perfusion	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)
Study the effects of nasal ventilation on cerebral tissue oxygenation	At inclusion (day 1) - step 1 to 6	Cerebral tissue oxygenation (% of O2) measured by NIRS (Near Infrared Spectroscopy) electrodes
Study the effects of nasal ventilation on regional lung ventilation distribution	At inclusion (day 1) - step 1 to 6	Evaluation of ventilation homogeneity by I thoracic electrical impedance tomography.

Trial Locations

Locations (1)

Service de Médecine Intensive Réanimation - Hôpital Pitié -Salpêtrière; 🇫🇷 Paris, France