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Recruiting NCT06547463

Effects of Nasal Airflow on Sleep in Tracheotomized Patients

— Observational Patients With Prolonged Weaning

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: nasal oxygenation device.
Who it may be relevant to
Registry conditions: Patients With Prolonged Weaning. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Other nasal oxygenation device
    Use of the nasal oxygenation device on one of the two nights during which polysomnography will be performed.

Primary outcome measures

  • Effects of nasal ventilation on sleep quality in ventilation-dependent tracheostomized patients. [Time frame: During the 12 hours duration of PSG]
Secondary outcome measures (6)
  • Effects of nasal ventilation on sleep duration [Time frame: During the 12 hours duration of PSG]
  • Effects of nasal ventilation on sleep architecture [Time frame: During the 12 hours duration of PSG]
  • Effects of nasal ventilation on the proportion of atypical sleep [Time frame: During the 12 hours duration of PSG]
  • Effects of nasal ventilation on minute ventilation [Time frame: During the 12 hours duration of PSG]
  • Effects of nasal ventilation on night-time awakenings [Time frame: During the 12 hours duration of PSG]
  • Effects of nasal ventilation on patient-ventilator asynchrony [Time frame: During the 12 hours duration of PSG]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Pitié Salpétrière HOSPITAL — Paris

Identifiers

NCT: NCT06547463 · APHP240636

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗