STimulation to Activate RespIration

ConditionsARDS (Moderate or Severe)AHRF Mechanically Ventilated ICU Patients

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorLungpacer Medical Inc.

About this trial

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).

Eligibility criteria

Qualifiers

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

PaO2:FiO2 ratio ≤300 mm Hg on PEEP ≥5 cm H2O, or

Disqualifiers

Hypoxemia is primarily attributable to acute exacerbation of chronic obstructive pulmonary disease, status asthmaticus, cardiogenic pulmonary edema, or pulmonary embolism.

Underlying chronic parenchymal lung disease that may make recovery/extubation a challenge (e.g., COPD, pulmonary fibrosis).

Broncho-pleural fistula at the time of eligibility assessment.

Require extracorporeal membrane oxygenation.