A single-arm, prospective, multicenter cohort study to assess the 30-day continued safety and effectiveness of the AeroPace System in patients on mechanical ventilation (MV) at least 96 hours and who have not weaned. This is a study collecting real-world data in a post-market setting.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Transvenous phrenic nerve stimulation to induce diaphragm contraction.
Adverse Event Profile
All Serious Adverse Events from enrollment to study exit and device- and/or procedure-related Adverse Events until successful wean, withdrawal/death, transfer or day 30 (whichever comes first).
Time frame: 30 days
Successful Weaning
Proportion of subjects successfully weaned by Day 30
Time frame: 30 days
Days on mechanical ventilation from time of initial placement procedure through Day 30.
Time frame: 30 days
Incidence of reintubation/reinstatement of MV through Day 30
Time frame: 30 days
Incidence of device/procedure related SAEs as compared to RESCUE 3 Treatment group subjects
Time frame: 30 days
Mortality through Day 30
Time frame: 30 days
Incidence of tracheostomy from enrollment through Day 30
Time frame: 30 days
ICU/hospital days from initial placement procedure to Day 32
Time frame: 32 days
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