About this trial
The goal of this clinical trial is to learn if non-invasive phrenic nerve stimulation works in adult acute cerebral infarction participants undergoing mechanical ventilation. It will also learn about the safety of non-invasive phrenic nerve stimulation. The main questions it aims to answer are:
1. Can non-invasive phrenic nerve stimulation shorten the duration of ventilator use and improve long-term prognosis? 2. What medical problems do participants have when taking non-invasive phrenic nerve stimulation? Researchers will compare non-invasive phrenic nerve stimulation to a sham stimulation to see if non-invasive phrenic nerve stimulation works.
Participants will:
1. Receive 14 days of non-invasive phrenic nerve stimulation or sham stimulation 2. Visit the clinic or call for follow-up at 90 days of onset
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age ≥ 18 years old
no gender restrictions
patient diagnosed with acute cerebral infarction (within 30 days of onset) through cranial CT or MRI
duration of mechanical ventilation ≥ 24 hours
Disqualifiers
there are other significant conditions that affect diaphragm function, such as severe malnutrition, irreversible respiratory pump failure caused by medullary or cervical cord injury, and irreversible damage to the phrenic nerve
significant agitation cannot be combined with transcutaneous electrical phrenic nerve stimulation
severe skin damage or infection at the electrode placement site
previous presence of severe lung disease (such as severe COPD, interstitial lung disease, pulmonary embolism, etc.), severe heart failure (NYHA Class IV)
Trial design
Parallel
Treatments tested in this trial
Transcutaneous electrical phrenic nerve stimulation
DeviceNon-invasive transcutaneous electrical phrenic nerve stimulation which can cause explicit contraction of the diaphragm, and the stimulation current may be set to 5-30mA depending on the participant's condition.
Sham (No Treatment)
DeviceThe stimulation current is set to 0.
Treatment groups
Trial outcomes
Primary outcomes
Mechanical ventilation duration
The total duration of mechanical ventilation, which is the time difference between starting mechanical ventilation and successfully weaning.
Secondary outcomes
Successful weaning rate
mRS at 90 days
Other outcomes
Tracheostomy rate
In-hospital mortality
Mortality at 90 days
ICU length of stay
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: