Clinical trial NCT06547463: Effects of Nasal Airflow on Sleep in Tracheotomized Patients
Official title: Effects of Nasal Airflow on Sleep in Tracheotomized Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patients With Prolonged Weaning
Keywords: tracheostomy
sleep
nasal airflow
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mechanically ventilated tracheotomized patients admitted for ventilation weaning.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Admission to PRRS for weaning from ventilation
3. Tracheotomy and nocturnal invasive mechanical ventilation
4. Indication for polysomnography by care team
5. Agreement to participate by patient or trusted person/relative and signature of consent form
6. Affiliation with a social security scheme or beneficiary

Exclusion Criteria:

1. Diseases of the central nervous system: cerebrovascular accident (CVA), multiple sclerosis (MS), epilepsy
2. Psychiatric illnesses (psychoses)
3. Hyperthermia (temperature \> 38.5°C)
4. Agitation, resuscitation delirium
5. Continuous use of sedatives
6. Patients under legal protection (guardianship/curatorship)
7. Patients deprived of liberty by judicial or administrative decision
8. Patients under AME
9. Pregnant or breast-feeding women

Primary outcomes:
measure: Effects of nasal ventilation on sleep quality in ventilation-dependent tracheostomized patients.
timeFrame: During the 12 hours duration of PSG
Secondary outcomes:
measure: Effects of nasal ventilation on sleep duration
timeFrame: During the 12 hours duration of PSG
measure: Effects of nasal ventilation on sleep architecture
timeFrame: During the 12 hours duration of PSG
measure: Effects of nasal ventilation on the proportion of atypical sleep
timeFrame: During the 12 hours duration of PSG
measure: Effects of nasal ventilation on minute ventilation
timeFrame: During the 12 hours duration of PSG
measure: Effects of nasal ventilation on night-time awakenings
timeFrame: During the 12 hours duration of PSG
measure: Effects of nasal ventilation on patient-ventilator asynchrony
timeFrame: During the 12 hours duration of PSG
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitié Salpétrière HOSPITAL
Study officials:
References: