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Reduced diaphragmatic activity during mechanical ventilation can lead to diaphragmatic disuse atrophy, atelectasis, increased lung stress and strain, and hemodynamic impairment. This, in turn, may prolong the duration of mechanical ventilation, make weaning more difficult, and even increase mortality. Synchronizing phrenic nerve stimulation to promote diaphragmatic activity may prevent ventilator-induced lung injury and ventilator-induced diaphragm dysfunction, thereby improving patient outcomes. Surgically implanted phrenic nerve stimulation has been used in certain neurological disorders, but the effects of percutaneous non-invasive synchronized phrenic nerve stimulation in patients with ARDS undergoing mechanical ventilation remain unclear and require further investigation.
Mechanical ventilation is an important treatment for patients with acute hypoxemic respiratory failure (AHRF). However, reduced diaphragmatic activity during mechanical ventilation can lead to diaphragmatic disuse atrophy, atelectasis, increased lung stress and strain, and hemodynamic impairment. This, in turn, may prolong the duration of mechanical ventilation, make weaning more difficult, and even increase mortality in these patients. In patients with AHRF undergoing mechanical ventilation, maintaining moderate spontaneous breathing under lung and diaphragm protective ventilation remains challenging. Synchronizing phrenic nerve stimulation to promote diaphragmatic activity may prevent ventilator-induced lung injury (VILI) and ventilator-induced diaphragm dysfunction (VIDD), thereby improving patient outcomes. Surgically implanted phrenic nerve stimulation has been used in certain neurological disorders, but the effects of percutaneous non-invasive synchronized phrenic nerve stimulation in patients with acute respiratory distress syndrome (ARDS) undergoing mechanical ventilation remain unclear and require further investigation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PNS group | Experimental | Electrical stimulation of the phrenic nerve in ARDS patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PNS group | Device | non-invasive phrenic nerve stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of enough Tidal volume | Percentage of stimulated breaths above the cut-off target tidal volume (3-6 ml/kg ideal body weigh) out of the total number of stimulated breaths | Procedure (from enrollment to extubation) |
| The speed of successful non-invasive electrical stimulation deployment | Time between first successful electrical phrenic stimulation and identification of the optimal stimulation locus in seconds | Procedure (from enrollment to extubation) |
| Measure | Description | Time Frame |
|---|---|---|
| Driving pressure | driving pressure was measured in the volume-controlled mode and calculated as the difference between plateau pressure and positive end-expiratory pressure | Procedure (from enrollment to extubation) |
| Diaphragm thickening fraction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ling liu, phD | Contact | 15901599659 | 18826401594@163.com |
| Name | Affiliation | Role |
|---|---|---|
| ling liu, phD | Zhongda Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital, School of Medicine, Southeast University | Recruiting | Nanjing | Jiangsu | 210009 | China |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D055397 | Ventilator-Induced Lung Injury |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D055370 | Lung Injury |
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Diaphragm thickening fraction measured with ultrasound of the diaphragm.
| up to 28 days |
| Diaphragm excursion | Diaphragm excursion measured with ultrasound of the diaphragm. | up to 28 days |
| Maximal inspiratory pressure (MIP) | MIP is measured by the mechanical ventilator during electromagnetic phrenic nerve stimulation. | Procedure (from enrollment to extubation) |
| ventilation distribution | ventilation distribution was measured by EIT | Procedure (from enrollment to extubation) |
| Respiratory system compliance | Respiratory system compliance is calculated as the ratio of tidal volume to the difference between plateau pressure and positive end-expiratory pressure. | Procedure (from enrollment to extubation) |