Multi-center, randomized, controlled, open-label Phase 2 feasibility trial. Subjects on mechanical ventilation (MV) for acute hypoxemic respiratory failure (AHRF) with lung injury (including subjects who meet criteria for acute respiratory distress syndrome (ARDS)) will be randomized 2:1 to diaphragm neurostimulation-assisted ventilation (DNAV) using the AeroNova System plus lung-protective ventilation (Treatment) vs. lung-protective ventilation alone (Control).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
During controlled MV when patients are not breathing, continuous diaphragm neurostimulation-assisted ventilation (DNAV) will be delivered in synchrony with each ventilator-delivered breath.
University of California San Diego
La Jolla, California, United States
RECRUITINGLouisiana State University Health Sciences
Shreveport, Louisiana, United States
RECRUITINGCleveland Clinic
Cleveland, Ohio, United States
Successful device insertion, mapping, and initiation of stimulation within 18 hours of meeting readiness-to-stimulate criteria
Time frame: Within 18 hours of meeting readiness to stimulate criteria
Stimulation delivered on >50% of ventilator-triggered breaths (ascertained from continuous recordings stored in the Console)
Time frame: 30 days
Rehabilitation sessions delivered at least once per day on >50% of days when the patient was breathing in assisted (patient-triggered) mechanical ventilation
Time frame: 30 days
Unanticipated serious adverse device events (USADE) and incidence of device- or procedure-related SAEs in the Treatment group
Time frame: 30 days
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Temple University
Philadelphia, Pennsylvania, United States
RECRUITINGPrisma Health
Columbia, South Carolina, United States
RECRUITINGUniversity Health Network (UHN)
Toronto, Ontario, Canada
RECRUITING