tracheotomy
Conditions
Interventions
mPES intervention group 1:The mPES catheter is connected to the electromyographic (EMG) device, and the catheter is guided into the pharynx through a nasal endoscope. The stimulating electrode ring is
mPES intervention group 2:The mPES catheter is connected to the electromyographic (EMG) device, and the catheter is guided into the pharynx through a nasal endoscope. The stimulating electrode ring is
mPES intervention group 3:The mPES catheter is connected to the electromyographic (EMG) device, and the catheter is guided into the pharynx through a nasal endoscope. The stimulating electrode ring is
mPES intervention gr
Sponsors
The Third Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Age between 18 and 80 years; onset time more than 1 month; first-ever ischemic or hemorrhagic stroke confirmed by CT and/or MRI; successfully weaned from mechanical ventilation but still tracheostomized; penetration or aspiration confirmed by videofluoroscopic swallowing study (PAS > 3); unable to tolerate cuff deflation or decannulation; normal hearing and able to follow instructions, with no significant cognitive impairment (MMSE >= 21); able to cooperate with mPES treatment and laryngoscopic examinations.
Exclusion criteria
Exclusion criteria: Patients with abnormal oropharyngeal anatomy, head and neck tumors, pharyngeal edema or hemorrhage that prevent safe mPES operation, or any other conditions that may render catheter placement unsafe; patients confirmed by upper airway assessment to have tracheal stenosis, cartilage collapse, or other conditions precluding cuff deflation; those with pre-existing dysphagia or any implanted electronic devices; patients with vocal cord paralysis, airway stenosis, tracheoesophageal fistula, history of epilepsy, or risk of seizure; those with severe cognitive impairment (MMSE < 13) or severe aphasia that affects communication; and patients with severe pulmonary infection or serious underlying diseases of major organs such as the heart, liver, or kidneys.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tracheostomy decannulation success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fiberoptic Endoscopic Evaluation of Swallowing;Capsaicin stimulation test;Diaphragmatic ultrasound;functional near-infrared spectroscopy; | — |
Countries
China
Contacts
Public ContactDou Zulin
The Third Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed