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

NCT ID: NCT07133932

Last Updated: 2025-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

590 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2027-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Cerebral Infarction Mechanical Ventilation Acute Cerebrovascular Accident Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Intervention group

Transcutaneous electrical phrenic nerve stimulation for 14 days

Group Type EXPERIMENTAL

Transcutaneous electrical phrenic nerve stimulation

Intervention Type 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.

Control group

Sham stimulation for 14 days

Group Type SHAM_COMPARATOR

Sham (No Treatment)

Intervention Type DEVICE

The stimulation current is set to 0.

Interventions

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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.

Intervention Type DEVICE

Sham (No Treatment)

The stimulation current is set to 0.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

Site Status

The First Hospital of Heibei Medical University

Shijiazhuang, Hebei, China

Site Status

Beijing Ditan Hospital, Capital Medical University

Beijing, , China

Site Status

Beijing Hui Min Hospital

Beijing, , China

Site Status

Sanbo Brain Hospital, Capital Medical University

Beijing, , China

Site Status

Dongzhimen Hospital Beijing University of Chinese Medicine

Beijing, , China

Site Status

Beijing Tongren Hospital, Capital Medical University

Beijing, , China

Site Status

The First Hospital of Fangshan District

Beijing, , China

Site Status

Beijing Daxing District People's Hospital

Beijing, , China

Site Status

Countries

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China

Central Contacts

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Linlin Fan

Role: CONTACT

86-010-83198899 ext. 8640

Facility Contacts

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Linlin Fan

Role: primary

86-010-83198899 ext. 8640

Ya Chang

Role: primary

86-0311-87156771

Meijuan Jiang

Role: primary

86-13811680287

Yanbo He

Role: primary

86-010-83912719

Zhonghua Shi

Role: primary

86-010-62856765

Yanen Lv

Role: primary

86-010-84015028

Qinglin Yang

Role: primary

86-010-58266018

Liang Chen

Role: primary

86-010-69313443-8184

Huiliang Yang

Role: primary

86-010-60283156

Other Identifiers

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2025-161-002

Identifier Type: -

Identifier Source: org_study_id

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