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

NCT07842484 | Not Yet Recruiting

• 1 other identifier: TONGUE-ICU
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Invasive Mechanical Ventilation; Extubation Time

Keywords

genioglossus (GG) muscle activity; non-invasive EMG

Outcome Measures

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.

  6 months

Secondary Outcomes (4)

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

  6 months

• Change in GG-EMG amplitude from baseline to physiological challenge quantified as RMS or peak-to-peak

  between Day 1 and Day 3 recordings

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

  1-3 days

• Correlation of EMG metrics and clinical variables (e.g., sedation depth, PCO₂, neurological status)

  6 months

Study Arms (1)

patients dependent on invasive mechanical ventilation and extubation

EXPERIMENTAL

Procedure: electromyography (EMG) of genioglossus (GG)

Interventions

electromyography (EMG) of genioglossus (GG) PROCEDURE

Measurement of efferent neural drive from respiratory centers to upper airways using electromyography (EMG) of genioglossus (GG) in patients dependent on invasive mechanical ventilation

patients dependent on invasive mechanical ventilation and extubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Known pregnancy
• Unstable intracranial pressure
• Pacemaker, internal defibrillator or pacing device wearers.
• Aneurysms at risk of rupture
• Severely impaired gas exchange despite optimal therapy
• GCS \< 5 or clinical signs of poor prognosis

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardy, 27100, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 25, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Locations

IT (1)