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Not yet recruiting NCT07133932

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

No phase Interventional Cerebral Infarction Mechanical Ventilation Acute Cerebrovascular Accident Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcutaneous electrical phrenic nerve stimulation, Sham (No Treatment).
Who it may be relevant to
Registry conditions: Cerebral Infarction, Mechanical Ventilation, Acute Cerebrovascular Accident, Adult. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

  • 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.

Primary outcome measures

  • Mechanical ventilation duration [Time frame: Successfully weaned from ventilater for 48 hours]
Secondary outcome measures (2)
  • Successful weaning rate [Time frame: Successfully weaned from ventilater for 48 hours]
  • mRS at 90 days [Time frame: 90 days of symptom onset]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 9 centers
  • Xuanwu Hospital Capital Medical University — Beijing
  • The First Hospital of Heibei Medical University — Shijiazhuang
  • Beijing Ditan Hospital, Capital Medical University — Beijing
  • Beijing Hui Min Hospital — Beijing
  • Sanbo Brain Hospital, Capital Medical University — Beijing
  • Dongzhimen Hospital Beijing University of Chinese Medicine — Beijing
  • Beijing Tongren Hospital, Capital Medical University — Beijing
  • The First Hospital of Fangshan District — Beijing
  • … and 1 more center

Identifiers

NCT: NCT07133932 · 2025-161-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗