Trial Parameters
Brief Summary
The study is a prospective, multi-center, randomized, controlled study using adaptive design to assess the evidence of safety and performance of the STIMIT Activator 1 System in the treatment of patients who have been mechanically ventilated for up to 7 days and are predicted to require additional minimum 48 hours of mechanical ventilation or longer.
Eligibility Criteria
Inclusion Criteria: 1. Are 21 years or older, and, 2. Have recently been placed on invasive MV (enroll and randomized as soon as possible after intubation), and have received no more than 7 days of MV 3. Are predicted to remain on mechanical ventilation for an additional 48 hours or longer post randomization Exclusion Criteria: 1. Patients that are actively treated with continuous infusion of neuromuscular blocking agents beyond the enrollment period. 2. Medical condition known to affect the phrenic nerve or respiratory muscles (examples of possible medical conditions that could affect the phrenic nerve provided in Annex 1 below). 3. Any patients with ICP probe. 4. 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. 5. Any non-remov