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NCT Number: NCT07133932

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

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

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Key information

Conditions

Cerebral Infarction Acute Cerebrovascular Accident Adult Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Infarction Ischemia Mechanical Ventilation Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu Hospital Capital Medical University, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutaneous electrical phrenic nerve stimulation

Device

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)

Device

The stimulation current is set to 0.

Primary outcomes

  1. Mechanical ventilation duration

    Time frame: 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 outcomes

  1. Successful weaning rate

    Time frame: Successfully weaned from ventilater for 48 hours

  2. mRS at 90 days

    Time frame: 90 days of symptom onset

Other outcomes

  1. Tracheostomy rate

    Time frame: Through ICU discharge, up to 90 days

  2. In-hospital mortality

    Time frame: Through ICU discharge, up to 90 days

  3. Mortality at 90 days

    Time frame: 90 days of symptom onset

  4. ICU length of stay

    Time frame: Through ICU discharge, up to 90 days

  5. ICU cost

    Time frame: Through ICU discharge, up to 90 days

  6. Quality of Life (EQ-5D-5L score) at 90 days

    Time frame: 90 days of symptom onset

  7. Incidence rate of ventilator-associated pneumonia

    Time frame: Through ICU discharge, up to 90 days

  8. Incidence rate of ventilator-induced diaphragmatic dysfunction

    Time frame: Through ICU discharge, up to 90 days

  9. Number of participants with electrode patch-associated skin injury

    Time frame: Day 14

Study contacts

Contact information is provided by the study sponsor or research team.

Linlin Fan

CONTACT

[email protected]

86-010-83198899 ext. 8640

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

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

Acronym: EDP-VENT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2025
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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