RecruitingNot ApplicableNCT05883163

STIMIT Activator 1 IDE Study

STIMIT Activator 1 Pivotal Study

Sponsor

Stimit AG

Enrollment

40 participants

Start Date

Jan 24, 2024

Study Type

INTERVENTIONAL

Conditions

Diaphragm Issues

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

Min Age: 21 Years

Inclusion Criteria3

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 Criteria14

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.
Physician thinks that the patient will not tolerate initial installation of the STIMIT respiratory sensor.
Anticipating withdrawal of life support and/or shift to palliation as the goal of care.
Known to be pregnant.
Participating in another clinical trial studying an experimental Intervention that could affect the study primary outcome.
Patients whose ultrasonographic assessment of right-sided diaphragmatic thickness would be too difficult (e.g. local subcutaneous emphysema surrounding the zone of apposition, large dressings in the zone of apposition that cannot be removed).
Patients with neck condition that would not allow placing the coils on the neck (e.g. open wounds that cannot be covered, skin at risk for burns).
Patients with significant spontaneous efforts (P0.1 \< - 2) that would not be at risk for diaphragmatic atrophy/ dysfunction.