STIMIT Activator 1 IDE Study (NCT05883163) | Clinical Trial Compass
RecruitingNot Applicable
STIMIT Activator 1 IDE Study
United States, Canada40 participantsStarted 2024-01-24
Plain-language 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.
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. Are 21 years or older, and,
✓. 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
✓. Are predicted to remain on mechanical ventilation for an additional 48 hours or longer post randomization
Exclusion criteria
✕. Patients that are actively treated with continuous infusion of neuromuscular blocking agents beyond the enrollment period.
✕. 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).
✕. Any patients with ICP probe.
✕. 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.
✕. 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.
✕. BMI \>40.
✕. Cardiogenic or septic shock with ongoing severe hemodynamic instability that cannot be stabilized within the enrollment period.
What they're measuring
1
Efffectiveness: Preservation of Diaphragm Thickness
Timeframe: Up to Day 10
2
Safety: Rate of device or procedure related serious adverse events (SAEs)