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
RECRUITINGWake Forest University School of Medicine
Winston-Salem, North Carolina, 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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Cleveland Clinic
Cleveland, Ohio, United States
RECRUITINGTemple University
Philadelphia, Pennsylvania, United States
RECRUITINGPrisma Health
Columbia, South Carolina, United States
RECRUITINGUniversity Health Network (UHN)
Toronto, Ontario, Canada
RECRUITING