Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
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

2026-07-01

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 (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