Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438302
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-21
Brief Title:
Effects of Nasal Ventilation on Cerebral and Pulmonary Function in Orally Intubated Patients
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Effects of Nasal Ventilation on Cerebral and Pulmonary Function in Orally Intubated Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VENTINA
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
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 0Lmin 30Lmin and 60Lmin respectively The last two conditions consist of applying humidified nasal air at 30Lmin and 60Lmin 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None