RecruitingNot ApplicableNCT06832306

STimulation to Activate RespIration

A Clinical Study Evaluating Temporary Transvenous Diaphragm Neurostimulation in Mechanically Ventilated Patients With Acute Hypoxemic Respiratory Failure


Sponsor

Lungpacer Medical Inc.

Enrollment

30 participants

Start Date

May 28, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether electrical stimulation of the diaphragm (the breathing muscle) can help people breathe better and potentially reduce the time they need mechanical ventilation. It targets patients who are in the ICU with acute respiratory failure — a sudden, severe inability to breathe on their own. The stimulation is delivered through a tube placed in the esophagus (food pipe). **You may be eligible if...** - You are 18 years or older - You are currently on mechanical ventilation or non-invasive breathing support in an ICU - Your breathing problems began within the past 2 weeks - Your blood oxygen levels are significantly low (meeting specific clinical criteria) **You may NOT be eligible if...** - Your breathing problem has been present for more than 2 weeks before needing respiratory support - You have conditions that would make the stimulation device unsafe to use Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPhrenic 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

View Full Details on ClinicalTrials.gov

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NCT06832306


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