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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06438302
Acronym
VENTINA
Enrollment
22
Registered
2024-05-31
Start date
2025-01-31
Completion date
2028-02-01
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxemic Acute Respiratory Failure

Keywords

nasal ventilation, orotracheal intubation, brain activity

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.

Interventions

DEVICEEEG activity measurement

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.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 6EEG spectral density spectrum of gamma frequency.

Secondary

MeasureTime frameDescription
Study the effects of nasal ventilation on cerebral perfusionAt inclusion (day 1) - step 1 to 6This 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 oxygenationAt inclusion (day 1) - step 1 to 6Cerebral tissue oxygenation (% of O2) measured by NIRS (Near Infrared Spectroscopy) electrodes
Study the effects of nasal ventilation on gas exchangeAt inclusion (day 1) - step 1 to 6Ratio of PaO2 (partial pressure of O2) /FiO2 (inspired oxygen fraction)
Study the effects of nasal ventilation on regional lung ventilation distributionAt inclusion (day 1) - step 1 to 6Evaluation of impedance variation by thoracic electrical impedance tomography.

Countries

France

Contacts

Primary ContactMartin Dres
martin.dres@aphp.fr0142167809

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026