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The passage of air through the nasal cavities generates rhythmic oscillations transmitted by the olfactory bulb to the brain, which induces cerebral activation in functional brain areas and is associated with better cognitive performance compared to oral breathing. Consequently, the abolition of nasal ventilation - intrinsic in tracheotomized and ventilated patients - could have deleterious effects on brain activity. Besides the loss of olfaction, the abolition of nasal ventilation could affect brain activity and sleep.
The hypothesis of the present study is that the restoration of nasal stimulation by the passage of humidified nasal airflow in tracheotomized and ventilated patients improves sleep quality, notably with a greater proportion of time spent in REM sleep.
The use of invasive mechanical ventilation via an endotracheal tube or tracheotomy involves bypassing the nasopharyngeal space and abolishing nasal ventilation. The first consequence is the loss of olfactory function. This function is quickly recovered when nasal ventilation is made possible. However, the abolition of nasal ventilation may have consequences beyond the loss of olfaction. The abolition of nasal ventilation in intubated rats inhibits these rhythmic oscillations, which can be restored by nasal sprays. In humans, nasal ventilation induces cerebral activity in functional brain areas and is associated with better cognitive performance compared to oral ventilation. In a model of intubated and ventilated rats, it has been shown that nasal sprays synchronized with the ventilator reduce hippocampal lesions compared to animals ventilated with an endotracheal tube without nasal sprays. Finally, in patients intubated with an endotracheal tube for toxic comas, the same nasal spray system restored brain activity and neural connectivity.
The aim of this study is to test the effects of nasal airflow of the sleep in tracheostomized patients who are still dependent to invasive mechanical ventilation. Patients will be investigated by a full polysomnography during two consecutive nights, with and without nasal airflow on the top of invasive mechanical ventilation, the two nights being randomized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with prolonged weaning | Mechanically ventilated tracheotomized patients admitted for ventilation weaning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nasal oxygenation device | Other | Use of the nasal oxygenation device on one of the two nights during which polysomnography will be performed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effects of nasal ventilation on sleep quality in ventilation-dependent tracheostomized patients. | The proportion of time spent in REM sleep over the total sleep time | During the 12 hours duration of PSG |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of nasal ventilation on sleep duration | Total sleep time as determined by polysomnography | During the 12 hours duration of PSG |
| Effects of nasal ventilation on sleep architecture | Proportion of time spent in stage 1, stage 2 and stage 3 sleeping |
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Inclusion Criteria:
Exclusion Criteria:
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Mechanically ventilated tracheotomized patients admitted for ventilation weaning.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin Dres, MD, PhD | Contact | 0142167809 | martin.dres@aphp.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pitié Salpétrière HOSPITAL | Recruiting | Paris | Paris | 75013 | France |
The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.
Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Researchers who provide a methodologically sound proposal
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| During the 12 hours duration of PSG |
| Effects of nasal ventilation on the proportion of atypical sleep | Proportion of time spent in atypical sleep | During the 12 hours duration of PSG |
| Effects of nasal ventilation on minute ventilation | Measurement of transcutaneous PaCO2 | During the 12 hours duration of PSG |
| Effects of nasal ventilation on night-time awakenings | Prevalence of night-time awakenings | During the 12 hours duration of PSG |
| Effects of nasal ventilation on patient-ventilator asynchrony | Asynchrony index (number of asynchronies/total number of respiratory cycles) | During the 12 hours duration of PSG |