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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
2026-07-01
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 (7)
University of California San Diego
La Jolla, California, United States
Louisiana State University Health Sciences
Shreveport, Louisiana, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 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