Phrenic Nerve Stimulation for Reducing Ventilation Duration in Acute Cerebral Infarction: A Multicenter Randomized Controlled Trial
NCT ID: NCT07133932
Last Updated: 2025-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
590 participants
INTERVENTIONAL
2025-09-01
2027-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Intervention group
Transcutaneous electrical phrenic nerve stimulation for 14 days
Transcutaneous 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.
Control group
Sham stimulation for 14 days
Sham (No Treatment)
The stimulation current is set to 0.
Interventions
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Transcutaneous 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.
Sham (No Treatment)
The stimulation current is set to 0.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Xuanwu Hospital, Beijing
OTHER
Responsible Party
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Locations
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Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
The First Hospital of Heibei Medical University
Shijiazhuang, Hebei, China
Beijing Ditan Hospital, Capital Medical University
Beijing, , China
Beijing Hui Min Hospital
Beijing, , China
Sanbo Brain Hospital, Capital Medical University
Beijing, , China
Dongzhimen Hospital Beijing University of Chinese Medicine
Beijing, , China
Beijing Tongren Hospital, Capital Medical University
Beijing, , China
The First Hospital of Fangshan District
Beijing, , China
Beijing Daxing District People's Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-161-002
Identifier Type: -
Identifier Source: org_study_id
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