STimulation to Activate RespIration

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).

NCT Number	NCT06832306
Lead Sponsor	Lungpacer Medical Inc.
Conditions	ARDS (Moderate or Severe), AHRF, Mechanically Ventilated ICU Patients
Enrollment	30 participants
Start Date	2025-05-28
Primary Completion	2026-09-30 (estimated)
Study Completion	2027-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-06