Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Transcutaneous electrical phrenic nerve stimulation for 14 days |
|
| Control group | Sham Comparator | Sham stimulation for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Successful weaning rate | Successfully weaned from ventilater for 48 hours | |
| mRS at 90 days | 90 days of symptom onset |
| Measure | Description | Time Frame |
|---|---|---|
| Tracheostomy rate | Through ICU discharge, up to 90 days | |
| In-hospital mortality | Through ICU discharge, up to 90 days | |
| Mortality at 90 days |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linlin Fan | Contact | 86-010-83198899 | 8640 | windspring7139@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital Capital Medical University | Beijing | Beijing Municipality | 100053 | China |
After the research is completed and the results are published, the project leader can be contacted to obtain the original data.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham (No Treatment) | Device | The stimulation current is set to 0. |
|
| 90 days of symptom onset |
| ICU length of stay | Through ICU discharge, up to 90 days |
| ICU cost | Through ICU discharge, up to 90 days |
| Quality of Life (EQ-5D-5L score) at 90 days | 90 days of symptom onset |
| Incidence rate of ventilator-associated pneumonia | Through ICU discharge, up to 90 days |
| Incidence rate of ventilator-induced diaphragmatic dysfunction | Through ICU discharge, up to 90 days |
| Number of participants with electrode patch-associated skin injury | Day 14 |
| The First Hospital of Heibei Medical University | Shijiazhuang | Hebei | 050000 | China |
|
| Beijing Ditan Hospital, Capital Medical University | Beijing | 100015 | China |
|
| Beijing Hui Min Hospital | Beijing | 100054 | China |
|
| Sanbo Brain Hospital, Capital Medical University | Beijing | 100093 | China |
|
| Dongzhimen Hospital Beijing University of Chinese Medicine | Beijing | 100700 | China |
|
| Beijing Tongren Hospital, Capital Medical University | Beijing | 100730 | China |
|
| The First Hospital of Fangshan District | Beijing | 102400 | China |
|
| Beijing Daxing District People's Hospital | Beijing | 102699 | China |
|
| ID | Term |
|---|---|
| D002544 | Cerebral Infarction |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
Not provided
Not provided