Study of Diaphragm Neurostimulation-Assisted Ventilation Versus Lung-Protective Ventilation in Adults on Mechanical Ventilation for Acute Hypoxemic Respiratory Failure

What this Trial Is About

Researchers are evaluating a new approach called diaphragm neurostimulation-assisted ventilation DNAV combined with lung-protective ventilation for adults on mechanical ventilation due to acute hypoxemic respiratory failure AHRF, including those with acute respiratory distress syndrome ARDS. This Phase 2, multi-center, randomized, controlled, open-label trial aims to test the feasibility of this device-assisted ventilation compared to standard lung-protective ventilation alone. Participants in the treatment group will receive a catheter placed in a vein to stimulate the phrenic nerves, activating the diaphragm in sync with the ventilator breaths using the AeroNova System. This stimulation aims to mimic resting breathing. The control group will receive lung-protective ventilation without the device. The study monitors device insertion success, stimulation delivery, and rehabilitation sessions over a 30-day period. During the trial, participants will be closely monitored for device performance, including whether stimulation is delivered on more than half of ventilator-triggered breaths and if rehabilitation sessions occur daily during assisted ventilation. Safety is also tracked through serious adverse events related to the device or procedure. Overall, involvement includes continuous monitoring and assessments during mechanical ventilation, with the primary evaluation period lasting 30 days from stimulation initiation.

STimulation to Activate RespIration