Measurement of Efferent Neural Drive From Respiratory Centers to Upper Airways Using Electromyography (EMG) of Genioglossus (GG) in Patients Dependent on Invasive Mechanical Ventilation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione IRCCS Policlinico San Matteo di Pavia

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • electromyography (EMG) of genioglossus (GG)

    Procedure/Surgery

    Measurement 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

10 Participants
are divided into 1 treatment group
Group A: patients dependent on invasive mechanical ventilation and extubationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion (with 95% confidence intervals) of participants meeting the stimulation success criterion.

Proportion (with 95% confidence intervals) of participants meeting the stimulation success criterion.

Time frame
6 months

Secondary outcomes

1

Proportion completing each measurement (Baseline - initial, Challenge, Baseline - subsequent).

Proportion completing each measurement (Baseline - initial, Challenge, Baseline - subsequent).

Time frame
6 months
2

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

Time frame
between Day 1 and Day 3 recordings
3

Change in GG-EMG amplitude between Day 1 and Day 3 recordings

Change in GG-EMG amplitude between Day 1 and Day 3 recordings

Time frame
1-3 days
4

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)

Time frame
6 months

Other outcomes

Sponsors and contacts

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