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

Not Applicable

Not yet recruiting

• Conditions: Cerebral Infarction; Acute Cerebrovascular Accident; Mechanical Ventilation; Adult

• Registration Number: NCT07133932
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-21
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-13
• Last Update Submitted: 2025-08-13
• Study First Posted: 2025-08-21
• Last Update Posted: 2025-08-21
• Study Start: 2025-09-01
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 590

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mechanical ventilation duration	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.

Secondary Outcome Measures

Name	Time	Method
Successful weaning rate	Successfully weaned from ventilater for 48 hours
mRS at 90 days	90 days of symptom onset

Trial Locations

Locations (9)

Xuanwu Hospital Capital Medical University; 🇨🇳 Beijing, Beijing, 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