NCT07133932

Phrenic Nerve Stimulation for Reducing Ventilation Duration in Acute Cerebral Infarction: A Multicenter Randomized Controlled Trial

Transcutaneous Electrical Phrenic Nerve Stimulation for Reducing Mechanical Ventilation Duration in Acute Cerebral Infarction: A Multicenter Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 590 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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

Conditions

• Cerebral Infarction
• Mechanical Ventilation
• Acute Cerebrovascular Accident
• Adult

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	Sham (No Treatment)	The stimulation current is set to 0.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-08-21
• Last updated: 2025-08-21

Locations

9 sites across 1 country: China