Measurement of Efferent Neural Drive From Respiratory Centers to Upper Airways Using Electromyography (EMG) of Genioglossus (GG) in Patients Dependent on Invasive Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Proportion (with 95% confidence intervals) of participants meeting the stimulation success criterion.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
patients dependent on invasive mechanical ventilation and extubation
干预措施: electromyography (EMG) of genioglossus (GG) (Procedure)
结局指标
主要结局
Proportion (with 95% confidence intervals) of participants meeting the stimulation success criterion.
时间窗: 6 months
Proportion (with 95% confidence intervals) of participants meeting the stimulation success criterion.
次要结局
- 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)
研究者
Michele Pagani
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia
