This clinical investigation is an open-label, multi-center RCT to demonstrate the safety and effective performance of the Lungpacer DPTS (plus standard of care) as compared to Control (standard of care only) in patients aged 18 years or older who are receiving mechanical ventilation. Eligible Subjects will have received mechanical ventilation for ≥96 hours (4 days) and have failed two weaning attempts. The goal or outcome is to show a numerically greater proportion of subjects weaned in the Treatment (Lungpacer DPTS) group as compared to the Control group.
The intended patient population is applicable for Lungpacer DPT because there are no noninvasive alternative treatments for patients who are difficult to wean from MV (i.e., ≥96 hours (4 days) on MV) or who have required prolonged MV (\>7 days). The intended patient population includes approximately one-third of all patients on mechanical ventilation. Under standard of care, approximately 50% of these patients will recover from mechanical ventilation (Jung, 2016). Standard of care involves daily weaning attempts, known as Spontaneous Breathing Trials (SBTs) or Ventilator Liberation Trials (VLTs) that are intended to encourage diaphragm use and strengthening over time.Therefore, Lungpacer DPT efficacy evaluation must be compared to standard of care in a Control group. Lack of recovery from mechanical ventilation may be due to the inability of a patient to participate in VLTs or weaning attempts, due to extensive diaphragm weakness or sedation, the inability of VLTs to induce sufficient diaphragm strengthening, or co-morbidities that prevent recovery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
223
Transvenous phrenic nerve stimulation to induce diaphragm contraction.
Stanford University Medical Center
Stanford, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
University of Florida, Shands
Gainesville, Florida, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Successful Weaning
The proportion of subjects who are successfully weaned will be statistically significantly greater for subjects randomized to Treatment (Lungpacer DPTS) compared to subjects randomized to Control.
Time frame: 30 days
Adverse Event Profile
Characterize the adverse event profile to support an observed consistent risk profile for subjects randomized to Treatment compared to subjects randomized to Control.
Time frame: 30 days
Days on MV
The average days on mechanical ventilation from Day 1 to removal from MV associated with successful weaning or Day 30, whichever comes first, will be statistically significantly smaller for subjects randomized to Treatment as compared to subjects randomized to Control.
Time frame: Successful weaning or Day 30
Maximal Inspiratory Pressure (MIP) Change
The mean improvement in inspiratory muscle strength as shown by the change in Maximal Inspiratory Pressure (MIP) from randomization to last available measure in subjects randomized to Treatment is superior to that in subjects randomized to Control.
Time frame: 30 days
Rapid Shallow Breathing Index (RSBI) Change
To determine change in Rapid Shallow Breathing Index (RSBI) from randomization to last available measure in subjects randomized to Treatment as compared to Control.
Time frame: 30 days
Mortality
To compare Treatment (Lungpacer DPTS) subjects to Control subjects for mortality through Day 30.
Time frame: 30 days
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U of Illinois at Chicago
Chicago, Illinois, United States
Edward Hines VA Hospital
Hines, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States
University of Louisville
Louisville, Kentucky, United States
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