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

Hypoxemic Acute Respiratory Failure Clinical Trial

— VENTINA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06438302
• Other study ID #: APHP240271
• Status: Not yet recruiting
• Start date: June 21, 2024
• Est. completion date: June 22, 2025

Study information

• Verified date: May 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Martin Dres
• Phone: 0142167809
• Email: martin.dres[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: June 22, 2025
• Est. primary completion date: June 22, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 150

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

Related Conditions & MeSH terms

• Hypoxemic Acute Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• EEG 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 37°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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Study the effects of nasal ventilation on cerebral perfusion	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)	At inclusion (day 1) - step 1 to 6
Secondary	Study the effects of nasal ventilation on cerebral tissue oxygenation	Cerebral tissue oxygenation (% of O2) measured by NIRS (Near Infrared Spectroscopy) electrodes	At inclusion (day 1) - step 1 to 6
Secondary	Study the effects of nasal ventilation on gas exchange	Ratio of PaO2 (partial pressure of O2) /FiO2 (inspired oxygen fraction)	At inclusion (day 1) - step 1 to 6
Secondary	Study the effects of nasal ventilation on gas exchange	Evaluation of PaCO2 (partial pressure of CO2) (mmHG)	At inclusion (day 1) - step 1 to 6
Secondary	Study the effects of nasal ventilation on regional lung ventilation distribution	Evaluation of impedance variation by thoracic electrical impedance tomography.	At inclusion (day 1) - step 1 to 6
Secondary	Study the effects of nasal ventilation on regional lung ventilation distribution	Evaluation of ventilation homogeneity by I thoracic electrical impedance tomography.	At inclusion (day 1) - step 1 to 6