About this 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

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Transcutaneous electrical phrenic nerve stimulation
  • Sham (No Treatment)

Treatment groups

590 Participants
are divided into 2 treatment groups

Locations

9
Xuanwu Hospital Capital Medical University100053, BeijingBeijing Municipality, China
The First Hospital of Heibei Medical University050000, ShijiazhuangHebei, China
Beijing Daxing District People's Hospital102699, Beijing China
Beijing Ditan Hospital, Capital Medical University100015, Beijing China

Sponsors and collaborators

Xuanwu Hospital, Beijing

Lead sponsor