A Clinical Study Evaluating Temporary Transvenous Diaphragm Neurostimulation in Mechanically Ventilated Patients With Acute Hypoxemic Respiratory Failure
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).
• Male or female, 18 years or older, and
• Able to provide informed consent or have a legally authorized representative (LAR) / Substitute Decision Maker (SDM) who can provide consent, and
• Have acute onset of new respiratory symptoms or dysfunction within the 2 weeks before onset of need for respiratory support, and
• Have moderate-to-severe arterial hypoxemia defined by one of:
‣ PaO2:FiO2 ratio \<≤200 mm Hg on PEEP ≥ 5 cm H2O, or
⁃ In the absence of an available arterial blood gas, SpO2 ≤97% on FiO2 ≥0.5 and PEEP ≥5 cm H2O with reliable SpO2 trace for the 2 hours immediately preceding eligibility assessment (this correlates to an upper limit of SpO2:FiO2 ratio of 235%) or
⁃ Are receiving inhaled nitric oxide for acute hypoxemia, or
⁃ Are being ventilated in the prone position for acute hypoxemia, and
• Have been mechanically ventilated for AHRF in the ICU for \<72 hours at the time of enrolment, and
• Are expected to require invasive mechanical ventilation ≥ 48 hours after enrollment in the opinion of the treating clinician