Non-invasive Phrenic Nerve Stimulation in ARDS Patient
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorSoutheast University, China
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult ARDS patients undergoing controlled mechanical ventilation
The duration of endotracheal intubation < 48 hrs
Disqualifiers
Neurological condition affecting motor neuron or muscle (e.g. ALS)
Paralysis of the phrenic nerve
Proven or suspected spinal cord injury
Conditions that limit diaphragm movement
Trial design
Design model
Single group
Treatments tested in this trial
PNS group
Devicenon-invasive phrenic nerve stimulation
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: PNS groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Procedure (from enrollment to extubation)2
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
Time frame
Procedure (from enrollment to extubation)Secondary outcomes
1
Driving pressure
driving pressure was measured in the volume-controlled mode and calculated as the difference between plateau pressure and positive end-expiratory pressure
Time frame
Procedure (from enrollment to extubation)2
Diaphragm thickening fraction
Diaphragm thickening fraction measured with ultrasound of the diaphragm.
Time frame
up to 28 days3
Diaphragm excursion
Diaphragm excursion measured with ultrasound of the diaphragm.
Time frame
up to 28 days4
Maximal inspiratory pressure (MIP)
MIP is measured by the mechanical ventilator during electromagnetic phrenic nerve stimulation.
Time frame
Procedure (from enrollment to extubation)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov