Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572280
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Non-invasive Phrenic Nerve Stimulation in ARDS Patient
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Non-invasive Phrenic Nerve Stimulation in ARDS Patients - a Feasibility Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None