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RECRUITING
NCT06832306
NA

STimulation to Activate RespIration

Sponsor: Lungpacer Medical Inc.

View on ClinicalTrials.gov

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

DEVICE

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