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

NCT06438302 | Recruiting

• 1 other identifier: APHP240271
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxemic Acute Respiratory Failure

Keywords

nasal ventilation; orotracheal intubation; brain activity

Outcome Measures

Primary Outcomes (1)

• Study the effects of nasal ventilation on brain electrical activity using electroencephalogram recording (EEG) in sedated orotracheally intubated patients.

  EEG spectral density spectrum of gamma frequency.

  At inclusion (day 1) - step 1 to 6

Secondary Outcomes (6)

• Study the effects of nasal ventilation on cerebral perfusion

  At inclusion (day 1) - step 1 to 6

• Study the effects of nasal ventilation on cerebral tissue oxygenation

  At inclusion (day 1) - step 1 to 6

• Study the effects of nasal ventilation on gas exchange

  At inclusion (day 1) - step 1 to 6

• Study the effects of nasal ventilation on gas exchange

  At inclusion (day 1) - step 1 to 6

• Study the effects of nasal ventilation on regional lung ventilation distribution

  At inclusion (day 1) - step 1 to 6

Study Arms (1)

Major mechanically ventilated patients intubated orotracheally

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.

Device: EEG activity measurement

Interventions

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.

Also known as: Post-intubation nasal ventilation, Additional blood samples (from care catheter 1.5 mL), Electrical impedance tomography

Major mechanically ventilated patients intubated orotracheally

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Médecine Intensive Réanimation - Hôpital Pitié -Salpêtrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Martin Dres

CONTACT

0142167809; martin.dres@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 31, 2024
• Study Start: January 31, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

FR (1)