NCT06572280

Non-invasive Phrenic Nerve Stimulation in ARDS Patient

Non-invasive Phrenic Nerve Stimulation in ARDS Patients - a Feasibility Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Southeast University, China · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• ARDS, Human
• Ventilator-Induced Lung Injury
• Diaphragm Injury

Interventions

Type	Name	Description
DEVICE	PNS group	non-invasive phrenic nerve stimulation

Timeline

• Start date: 2024-08-01
• Primary completion: 2024-12-30
• Completion: 2025-01-30
• First posted: 2024-08-27
• Last updated: 2024-08-27

Locations

1 site across 1 country: China