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.
The objective of this clinical investigation is to evaluate the safety and effectiness of the STIMIT Activator 1 System in patients who are on invasive mechanical ventilation (MV) and thus are at risk of diaphragmatic dysfunction/atrophy. The study is expected to enroll 40 participants at up to 8 centers focusing on North American sites (main focus USA, \> 50% of study enrollment from US site). An interim analysis will be conducted after 30 participants have been enrolled and compelted their study follow-up to reconfirm sample size (adaptive design). Participants will be followed for up to 10 days or until they are successfully extubated (weaned) from mechanical ventilation, expire prior to extubation, or withdraw consent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
The Stimit Activator 1 System will be used to stimulate the phrenic nerve resulting in diaphragm activation.
Yale New Haven Hospital
New Haven, Connecticut, United States
RECRUITINGBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RECRUITINGUniversity of Virginia Medical Center
Charlottesville, Virginia, United States
RECRUITINGEfffectiveness: Preservation of Diaphragm Thickness
The intra-individual change in diaphragm thickness will be measured daily via ultrasound and compared between intervention and control groups.
Time frame: Up to Day 10
Safety: Rate of device or procedure related serious adverse events (SAEs)
Events will be collected for intervention group during the course of treatment.
Time frame: Up to Day 10
Preservation of Diaphragm Thickness
The intra-individual change in diaphragm thickness will be measured daily via ultrasound and compared between intervention and control groups.
Time frame: Up to Day 3
Time to Rapid Shallow Breathing Index (RSBI) < 105
Time from intubation to RSBI\<105 breaths/min/L in days will be compared between intervention and control groups.
Time frame: Up to Day 10
Maximum Inspiratory Pressure (MIP) at extubation
MIP at extubation will be compared between intervention and control groups.
Time frame: Up to Day 10
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St Michael's Hospital Unity Health Toronto
Toronto, Canada
RECRUITING