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

NCT07133932 · tracked via the Priya Life Science China tracker

Sponsor

Xuanwu Hospital, Beijing

Phase

Not applicable

Started

2025-09-01

Last updated

2025-08-21

Condition(s) studied

Cerebral InfarctionMechanical VentilationAcute Cerebrovascular AccidentAdult

Investigational drug(s) / intervention(s)

Transcutaneous electrical phrenic nerve stimulationSham (No Treatment)

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.

Sham (No Treatment): The stimulation current is set to 0.

Study 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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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

Primary outcome measure(s)

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.

Trial sites (9)

Facility	City	Region
Xuanwu Hospital Capital Medical University	Beijing	Beijing Municipality
The First Hospital of Heibei Medical University	Shijiazhuang	Hebei
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07133932 on ClinicalTrials.gov ↗ ← All trials in China