Zhongda Hospital, School of Medicine, Southeast University
Nanjing, Jiangsu, 210009, China
Location status: Recruiting
NCT Number: NCT06572280
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.
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Interventional
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Nanjing, Jiangsu, 210009, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
non-invasive phrenic nerve stimulation
Time frame: Procedure (from enrollment to extubation)
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
Time frame: Procedure (from enrollment to extubation)
Time between first successful electrical phrenic stimulation and identification of the optimal stimulation locus in seconds
Time frame: Procedure (from enrollment to extubation)
driving pressure was measured in the volume-controlled mode and calculated as the difference between plateau pressure and positive end-expiratory pressure
Time frame: up to 28 days
Diaphragm thickening fraction measured with ultrasound of the diaphragm.
Time frame: up to 28 days
Diaphragm excursion measured with ultrasound of the diaphragm.
Time frame: Procedure (from enrollment to extubation)
MIP is measured by the mechanical ventilator during electromagnetic phrenic nerve stimulation.
Time frame: Procedure (from enrollment to extubation)
ventilation distribution was measured by EIT
Time frame: Procedure (from enrollment to extubation)
Respiratory system compliance is calculated as the ratio of tidal volume to the difference between plateau pressure and positive end-expiratory pressure.
Contact information is provided by the study sponsor or research team.
Southeast University, China
Other
Non-invasive Phrenic Nerve Stimulation in ARDS Patients - a Feasibility Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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