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STimulation to Activate RespIration
Sponsor: Lungpacer Medical Inc.
Summary
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).
Official title: A Clinical Study Evaluating Temporary Transvenous Diaphragm Neurostimulation in Mechanically Ventilated Patients With Acute Hypoxemic Respiratory Failure
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-05-28
Completion Date
2026-12
Last Updated
2026-01-09
Healthy Volunteers
No
Interventions
Phrenic Nerve Stimulation
During controlled MV when patients are not breathing, continuous diaphragm neurostimulation-assisted ventilation (DNAV) will be delivered in synchrony with each ventilator-delivered breath.
Locations (6)
University of California San Diego
La Jolla, California, United States
Louisiana State University Health Sciences
Shreveport, Louisiana, United States
Cleveland Clinic
Cleveland, Ohio, United States
Temple University
Philadelphia, Pennsylvania, United States
Prisma Health
Columbia, South Carolina, United States
University Health Network (UHN)
Toronto, Ontario, Canada