STIMIT Activator 1 IDE Pivotal Study

Inclusion 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 onMV for an additional 48 hours or longer*

• Prediction at time of enrollment

Exclusion Criteria:

1. Patients that are planned to be treated with continuous infusion of neuromuscularblocking 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 pulmonaryfibrosis)
5. Patients with metallic device implants or body penetrating metallic devices in theupper body area within 30cm (12inches) from the coils; known anatomy or devices in theneck area (e.g., ECMO cannulas in the neck area, collars or cranial appliances) thatwould interfere with headset placement or stimulation
6. Any non-removable electrical / electronic device (device internal or external) thatmay be prone to interaction with, or interference from the STIMIT Activator, such aspacemakers, implantable defibrillators, implanted medication pumps, bio-stimulators,deep brain stimulators, implanted nerve stimulator, deep brain stimulators or cochleardevice implants
7. BMI >40
8. Cardiogenic or septic shock with ongoing severe hemodynamic instability as definedaccording 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 STIMITrespiratory 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 thatcould affect the study primary outcome.
13. Patients whose ultrasonographic assessment of right-sided diaphragmatic thicknesswould be difficult (e.g. local subcutaneous emphysema surrounding the zone ofapposition, large dressings in the zone of apposition that cannot be removed).
14. Patients with any neck incision, bruising, or other skin condition that places thesubject at risk for burns.