Status:
NOT_YET_RECRUITING
Phrenic Nerve Stimulation for Reducing Ventilation Duration in Acute Cerebral Infarction: A Multicenter Randomized Controlled Trial
Lead Sponsor:
Xuanwu Hospital, Beijing
Conditions:
Cerebral Infarction
Mechanical Ventilation
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
590 Patients enrolled
Trial Details
Trial ID
NCT07133932
Start Date
September 1 2025
End Date
December 31 2027
Last Update
August 21 2025
Active Locations (9)
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1
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100053
2
The First Hospital of Heibei Medical University
Shijiazhuang, Hebei, China, 050000
3
Beijing Ditan Hospital, Capital Medical University
Beijing, China, 100015
4
Beijing Hui Min Hospital
Beijing, China, 100054