Acute Cerebrovascular Accident, Adult, Cerebral Infarction, Mechanical Ventilation
Conditions
Brief summary
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
Interventions
DEVICETranscutaneous electrical phrenic nerve stimulation
Non-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.
DEVICESham (No Treatment)
The stimulation current is set to 0.
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * patient or their legal guardian agrees to participate in the study and signs an informed consent form
Exclusion criteria
* 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) * sepsis or shock requiring high-dose vasopressors * the terminal state of the disease or expected survival period does not exceed 7 days * pacemaker implantation * pregnant or lactating women * patients whose family members express their willingness to withdraw for treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical ventilation duration | Successfully weaned from ventilater for 48 hours | The total duration of mechanical ventilation, which is the time difference between starting mechanical ventilation and successfully weaning. |
Secondary
| Measure | Time frame |
|---|---|
| Successful weaning rate | Successfully weaned from ventilater for 48 hours |
| mRS at 90 days | 90 days of symptom onset |
Other
| Measure | Time frame |
|---|---|
| ICU length of stay | Through ICU discharge, up to 90 days |
| ICU cost | Through ICU discharge, up to 90 days |
| Quality of Life (EQ-5D-5L score) at 90 days | 90 days of symptom onset |
| Tracheostomy rate | Through ICU discharge, up to 90 days |
| Incidence rate of ventilator-induced diaphragmatic dysfunction | Through ICU discharge, up to 90 days |
| Number of participants with electrode patch-associated skin injury | Day 14 |
| Incidence rate of ventilator-associated pneumonia | Through ICU discharge, up to 90 days |
| In-hospital mortality | Through ICU discharge, up to 90 days |
| Mortality at 90 days | 90 days of symptom onset |
Countries
China
Contacts
Primary ContactLinlin Fan
Outcome results
None listed