Phrenic Nerve Stimulation for Reducing Ventilation Duration in Acute Cerebral Infarction: A Multicenter Randomized Controlled Trial (EDP-VENT)

Capital Medical University

Status: Not yet enrolling

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

Treatments: Device: Sham (No Treatment); Device: Transcutaneous electrical phrenic nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07133932

2025-161-002

Details and patient eligibility

About

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

Enrollment: 590 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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590 participants in 2 patient groups

Intervention group

Experimental group

Description:

Transcutaneous electrical phrenic nerve stimulation for 14 days

Treatment:

Device: Transcutaneous electrical phrenic nerve stimulation

Control group

Sham Comparator group

Description:

Sham stimulation for 14 days

Treatment:

Device: Sham (No Treatment)