STIMIT Activator 1 IDE Pivotal Study

Eligibility Criteria

• 1. Informed consent in writing from patient or the legally authorized representative
• 2. Are 21 years or older, and,
• 3. Have been on invasive mechanical ventilation ≤ 48hours and are predicted to remain on MV for an additional 48 hours or longer\*
• * Prediction at time of enrollment
• 1. Patients that are planned to be treated with continuous infusion of neuromuscular blocking agents beyond the 48h enrollment period.
• 2. Medical condition known to affect the phrenic nerve or respiratory muscles (non-exclusive list of medical conditions that could affect the phrenic nerve)
• 3. Any patients with ICP probe
• 4. Pre-existing severe chronic pulmonary disease (COPD GOLD stage IV, severe pulmonary fibrosis)
• 5. Patients with metallic device implants or body penetrating metallic devices in the upper body area within 30cm (12inches) from the coils; known anatomy or devices in the neck area (e.g., ECMO cannulas in the neck area, collars or cranial appliances) that would interfere with headset placement or stimulation
• 6. Any non-removable electrical / electronic device (device internal or external) that may be prone to interaction with, or interference from the STIMIT Activator, such as pacemakers, implantable defibrillators, implanted medication pumps, bio-stimulators, deep brain stimulators, implanted nerve stimulator, deep brain stimulators or cochlear device implants
• 7. BMI \>40
• 8. Cardiogenic or septic shock with ongoing severe hemodynamic instability as defined according to American College of Chest Physicians (Bone et al. 1992) (Singer et al. 2016)) that cannot be stabilized within the 48 hours enrollment period
• 9. Physician thinks that the patient will not tolerate initial installation of the STIMIT respiratory sensor.
• 10. Anticipating withdrawal of life support and/or shift to palliation as the goal of care (refer to Annex 2)
• 11. Known to be pregnant
• 12. Participating in another clinical trial studying an experimental Intervention that could affect the study primary outcome.
• 13. Patients whose ultrasonographic assessment of right-sided diaphragmatic thickness would be difficult (e.g. local subcutaneous emphysema surrounding the zone of apposition, large dressings in the zone of apposition that cannot be removed).
• 14. Patients with any neck incision, bruising, or other skin condition that places the subject at risk for burns.