About this trial
Muscle activity in the upper airway is influenced by specific states such as anesthesia, sleep, wakefulness, and the phases of respiration. The hypoglossal nerve, which innervates the genioglossus muscle, receives input from the brain's sleep-wake center, respiratory pattern-generating neurons, chemoreceptors, and airway negative pressure receptors. Preliminary activation of the genioglossus muscle and other upper airway dilators by the hypoglossal nerve occurs approximately 50-200 ms before innervation of the phrenic motor neurons and the subsequent action of the diaphragm. The forward movement of the genioglossus increases the stiffness and diameter of the upper airway, effectively counteracting collapse forces during inspiration. Assessing genioglossus function could prove critical in determining the optimal timing for extubation. This requires a methodology to evaluate the upper airway by measuring genioglossus activity in intubated patients. In the future, this could provide an objective measure for assessing suitability for extubation. This study explores a method for measuring the electrical activity of the upper airway muscles and the diaphragm in ventilated patients and correlates the results in a systematic view.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older.
Dependent on invasive mechanical ventilation in ICU
Awakening patient: improving neurological status (+2 points on the GCS compared to admission)
Patient weaning from mechanical ventilation: presence of ventilator-recorded weaning trigger.
Disqualifiers
Known pregnancy
Unstable intracranial pressure
Pacemaker, internal defibrillator or pacing device wearers.
Aneurysms at risk of rupture
Trial design
Single group
Treatments tested in this trial
electromyography (EMG) of genioglossus (GG)
Procedure/SurgeryMeasurement of efferent neural drive from respiratory centers to upper airways using electromyography (EMG) of genioglossus (GG) in patients dependent on invasive mechanical ventilation
Treatment groups
Trial outcomes
Primary outcomes
Proportion (with 95% confidence intervals) of participants meeting the stimulation success criterion.
Proportion (with 95% confidence intervals) of participants meeting the stimulation success criterion.
Secondary outcomes
Proportion completing each measurement (Baseline - initial, Challenge, Baseline - subsequent).
Proportion completing each measurement (Baseline - initial, Challenge, Baseline - subsequent).
Change in GG-EMG amplitude from baseline to physiological challenge quantified as RMS or peak-to-peak
Change in GG-EMG amplitude from baseline to physiological challenge quantified as RMS or peak-to-peak
Change in GG-EMG amplitude between Day 1 and Day 3 recordings
Change in GG-EMG amplitude between Day 1 and Day 3 recordings
Correlation of EMG metrics and clinical variables (e.g., sedation depth, PCO₂, neurological status)
Correlation of EMG metrics and clinical variables (e.g., sedation depth, PCO₂, neurological status)
Sponsors and contacts
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