Actively Recruiting
Effects of Nasal Ventilation on Cerebral and Pulmonary Function in Orally Intubated Patients
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-12-03
22
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how nasal ventilation affects brain and lung function in adults with hypoxemic acute respiratory failure who are sedated and intubated through the mouth. The study focuses on how breathing through the nose with humidified air may influence brain electrical activity, cerebral blood flow, oxygen levels in brain tissue, and lung ventilation compared to no nasal airflow. This research addresses concerns that oral intubation may alter brain activity and respiratory control due to the loss of natural nasal airflow. Participants will undergo six experimental conditions using a nasal ventilation device delivering humidified air at different flow rates (0, 30, and 60 liters per minute) and oxygen levels (21% and 100%). Each condition lasts 30 minutes and includes a negative control with no airflow. Measurements include electroencephalogram (EEG) recordings, cerebral near-infrared spectroscopy (NIRS), thoracic electrical impedance tomography, Doppler velocity, and blood gas analysis to assess brain and lung function. During the study, patients will be monitored continuously while sedated and intubated. The research team will record EEG activity to study brain electrical patterns, cerebral perfusion and oxygenation, gas exchange, and lung ventilation distribution under each nasal ventilation condition. The total assessment happens on day 1 at inclusion, with multiple recordings and blood samples taken after every experimental step. This detailed monitoring aims to understand how nasal airflow impacts cerebral and pulmonary function in this patient group.
CONDITIONS
Brief Title
Effects of Nasal Ventilation on Cerebral and Pulmonary Function in Orally Intubated Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of hypoxemic acute respiratory failure
- Intubated and mechanically ventilated for less than 4 days
- PaO2/FiO2 ratio less than 200
- Richmond Agitation-Sedation Scale (RASS) score less than -4
- Consent obtained from next of kin
- Patient has health insurance coverage
You will not qualify if you...
- Central nervous system diseases such as stroke, multiple sclerosis, or epilepsy
- Psychiatric illnesses including psychosis or depression documented in medical records
- Hemodynamic instability with noradrenalin dosage greater than 2 mg/hour
- Patient on automatic mechanical ventilation (AME)
- Patients under legal protection such as guardianship or curatorship
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 day
Participants undergo six successive 30-minute experimental conditions with different nasal ventilation settings while sedated and intubated. Measurements of brain electrical activity, cerebral perfusion and oxygenation, gas exchange, and lung ventilation distribution are recorded during these conditions.
1 visit (in-person) including all experimental conditions and measurements
Trial Site Locations
Total: 1 location
1
Service de Médecine Intensive Réanimation - Hôpital Pitié -Salpêtrière
Paris, France, 75013
Actively Recruiting
Research Team
M
Martin Dres
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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