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

NCT07133932 | Not Yet Recruiting

• 1 other identifier: 2025-161-002
• Study Type: interventional
• Target: 590
• Locations: 1 country
• Sites: 9

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. 1.Can non-invasive phrenic nerve stimulation shorten the duration of ventilator use and improve long-term prognosis?
2. 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.
3. 3.Receive 14 days of non-invasive phrenic nerve stimulation or sham stimulation
4. 4.Visit the clinic or call for follow-up at 90 days of onset

Conditions

Cerebral Infarction; Mechanical Ventilation; Acute Cerebrovascular Accident; Adult

Outcome Measures

Primary Outcomes (1)

• Mechanical ventilation duration

  The total duration of mechanical ventilation, which is the time difference between starting mechanical ventilation and successfully weaning.

  Successfully weaned from ventilater for 48 hours

Secondary Outcomes (2)

• Successful weaning rate

  Successfully weaned from ventilater for 48 hours

• mRS at 90 days

  90 days of symptom onset

Other Outcomes (9)

• Tracheostomy rate

  Through ICU discharge, up to 90 days

• In-hospital mortality

  Through ICU discharge, up to 90 days

• Mortality at 90 days

  90 days of symptom onset

Study Arms (2)

Intervention group

EXPERIMENTAL

Transcutaneous electrical phrenic nerve stimulation for 14 days

Device: Transcutaneous electrical phrenic nerve stimulation

Control group

SHAM COMPARATOR

Sham stimulation for 14 days

Device: Sham (No Treatment)

Interventions

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.

Intervention group

Sham (No Treatment) DEVICE

The stimulation current is set to 0.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (9)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

The First Hospital of Heibei Medical University

Shijiazhuang, Hebei, 050000, China

Location

Beijing Ditan Hospital, Capital Medical University

Beijing, 100015, China

Location

Beijing Hui Min Hospital

Beijing, 100054, China

Location

Sanbo Brain Hospital, Capital Medical University

Beijing, 100093, China

Location

Dongzhimen Hospital Beijing University of Chinese Medicine

Beijing, 100700, China

Location

Beijing Tongren Hospital, Capital Medical University

Beijing, 100730, China

Location

The First Hospital of Fangshan District

Beijing, 102400, China

Location

Beijing Daxing District People's Hospital

Beijing, 102699, China

Location

MeSH Terms

Conditions

Cerebral Infarction; Stroke

Condition Hierarchy (Ancestors)

Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Linlin Fan

CONTACT

86-010-83198899; windspring7139@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 21, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

CN (9)