NCT07133932尚未招募不适用
Transcutaneous Electrical Phrenic Nerve Stimulation for Reducing Mechanical Ventilation Duration in Acute Cerebral Infarction: A Multicenter Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 590
- 试验地点
- 9
- 主要终点
- Mechanical ventilation duration
研究概览
简要总结
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：
- Can non-invasive phrenic nerve stimulation shorten the duration of ventilator use and improve long-term prognosis?
- 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:
- Receive 14 days of non-invasive phrenic nerve stimulation or sham stimulation
- Visit the clinic or call for follow-up at 90 days of onset
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control group
Sham Comparator
Sham stimulation for 14 days
干预措施: Sham (No Treatment) (Device)
Intervention group
Experimental
Transcutaneous electrical phrenic nerve stimulation for 14 days
干预措施: Transcutaneous electrical phrenic nerve stimulation (Device)
结局指标
主要结局
Mechanical ventilation duration
时间窗: 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.
次要结局
- Successful weaning rate(Successfully weaned from ventilater for 48 hours)
- mRS at 90 days(90 days of symptom onset)
研究者
研究点 (9)
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