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ClinicalTrials.gov ID

NCT07133932

Lead Sponsor

Xuanwu Hospital, BeijingOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

590Estimated

Last Update Posted

Aug 21, 2025Actual

Start Date

Sep 1, 2025Estimated

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

Official Title

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

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

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

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

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Triple

Lead Sponsor

Xuanwu Hospital, BeijingOTHER

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