Nerve Stimulation to Help Stroke Patients Come Off a Breathing Machine
Tests non-invasive phrenic nerve stimulation in adults with stroke who need a breathing machine.
Plain-language title generated from the registry record
Registry title: Phrenic Nerve Stimulation for Reducing Ventilation Duration in Acute Cerebral Infarction: A Multicenter Randomized Controlled Trial
Key facts
- Where
- Beijing and Shijiazhuang, ChinaSee the 9 sites
Where in China
- Beijing Daxing District People's HospitalBeijing, ChinaNo longer taking part
- Beijing Ditan Hospital, Capital Medical UniversityBeijing, ChinaNo longer taking part
- Beijing Hui Min HospitalBeijing, ChinaNo longer taking part
- Beijing Tongren Hospital, Capital Medical UniversityBeijing, ChinaNo longer taking part
- Dongzhimen Hospital, Beijing University of Chinese MedicineBeijing, ChinaNo longer taking part
- Sanbo Brain Hospital, Capital Medical UniversityBeijing, ChinaNo longer taking part
- The First Hospital of Fangshan DistrictBeijing, ChinaNo longer taking part
- Xuanwu Hospital, Capital Medical UniversityBeijing, ChinaNo longer taking part
- The First Hospital of Heibei Medical UniversityShijiazhuang, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xuanwu Hospital, Beijing
- Trial code
- NCT07133932
- Record updated
- 21 August 2025
- Original description
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：Read full original descriptionShow less
Transcutaneous Electrical Phrenic Nerve Stimulation for Reducing Mechanical Ventilation Duration in Acute Cerebral Infarction: A Multicenter Randomized Controlled 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
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: previous presence of severe lung disease (such as severe COPD, interstitial lung disease, pulmonary embolism, etc.), severe heart failure (NYHA Class IV); 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; severe skin damage or infection at the electrode placement site; the terminal state of the disease or expected survival period does not exceed 7 days; significant agitation cannot be combined with transcutaneous electrical phrenic nerve stimulation; sepsis or shock requiring high-dose vasopressors; pacemaker implantation; pregnant or lactating women; patients whose family members express their willingness to withdraw for treatment.