Health Trials

About this trial

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 criteria

Qualifiers

Male or female, 18 years or older, and

Able to provide informed consent or have a legally authorized representative (LAR) / Substitute Decision Maker (SDM) who can provide consent, and

Have acute onset of new respiratory symptoms or dysfunction within the 2 weeks before onset of need for respiratory support, and

PaO2:FiO2 ratio ≤300 mm Hg on PEEP ≥5 cm H2O, or

Disqualifiers

Hypoxemia is primarily attributable to acute exacerbation of chronic obstructive pulmonary disease, status asthmaticus, cardiogenic pulmonary edema, or pulmonary embolism.

Underlying chronic parenchymal lung disease that may make recovery/extubation a challenge (e.g., COPD, pulmonary fibrosis).

Broncho-pleural fistula at the time of eligibility assessment.

Require extracorporeal membrane oxygenation.

Trial design

Treatments tested in this trial

  • Phrenic Nerve Stimulation

Treatment groups

30 Participants
are divided into 2 treatment groups

Locations

7
Canada
University Health Network (UHN)M5G 2C4, TorontoOntario, Canada
United States
California
University of California San Diego92037, La Jolla United States
Louisiana
Louisiana State University Health Sciences71103, Shreveport United States
North Carolina
Wake Forest University School of Medicine27157, Winston-Salem United States

Sponsors and collaborators

Lungpacer Medical Inc.

Lead sponsor

Source ClinicalTrials.gov