NCT06438302 Effects of Nasal Ventilation on Cerebral and Pulmonary Function in Orally Intubated Patients
| NCT ID | NCT06438302 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Hypoxemic Acute Respiratory Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 22 participants |
| Start Date | 2025-01-31 |
| Primary Completion | 2028-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 22 participants in total. It began in 2025-01-31 with a primary completion date of 2028-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06438302 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hypoxemic Acute Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06438302 currently recruiting?
Yes, NCT06438302 is actively recruiting participants. Contact the research team at martin.dres@aphp.fr for enrollment information.
Where is the NCT06438302 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06438302 clinical trial?
NCT06438302 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 22 participants.