A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning From Mechanical Ventilation
- Conditions
- Ventilator Induced Diaphragm Dysfunction
- Interventions
- Device: Lungpacer Diaphragm Pacing Therapy
- Registration Number
- NCT03783884
- Lead Sponsor
- Lungpacer Medical Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 223
- Are 18 years or older, and,
- Have been mechanically ventilated for ≥96 hours (4 days), and,
- Have satisfied the Readiness-to-Wean criteria, and,
- Have failed at least 2 weaning attempts (that were conducted at least 48 hours after initiation of MV, and, that were conducted on different calendar days, and, at least one of which was the protocol-specific Ventilator Liberation Trial).
- MIP (absolute value) >50 cm H2O;
- Invasive mechanical ventilation >90 days;
- Currently on ECMO;
- Weaning failure due to hypervolemia;
- Medical history (including imaging) or known anatomy that prevents percutaneous insertion of the Catheter into the intended thoracic vein on the left side.
- Clinically overt congestive heart failure that is preventing weaning;
- Currently being treated with neuromuscular blockade;
- Pre-existing neurological, neuromuscular or muscular disorder that could affect the respiratory muscles;
- Pre-existing severe chronic pulmonary fibrosis;
- Pleural effusions occupying greater than one third of the pleural space on either side;
- BMI >45 kg/m2;
- Known or suspected phrenic nerve paralysis;
- Any electrical device (implanted or external) that may be prone to interaction with, or interference from the Lungpacer DPTS including neurological pacing/stimulator devices, cardiac pacemakers and defibrillators;
- Current hemodynamic instability, sepsis or septic shock;
- Prior bacteremia reported within the last 48 hours;
- Anticipating withdrawal of life support and/or shift to palliation as the goal of care;
- Known or suspected to be pregnant or lactating;
- Currently being treated in another clinical trial studying an experimental treatment that could affect the study primary outcome.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Lungpacer Diaphragm Pacing Therapy Subject receives Lungpacer Catheter for transvenous phrenic nerve stimulation to deliver Diaphragm Pacing Therapy Sessions. DPT sessions are 6 sets of 10, delivered twice daily, for a total of 120 stimulation reps per day, plus standard of care for weaning from mechanical ventilation.
- Primary Outcome Measures
Name Time Method Successful Weaning 30 days 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.
Adverse Event Profile 30 days Characterize the adverse event profile to support an observed consistent risk profile for subjects randomized to Treatment compared to subjects randomized to Control.
- Secondary Outcome Measures
Name Time Method Days on MV Successful weaning or Day 30 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.
Maximal Inspiratory Pressure (MIP) Change 30 days 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.
Rapid Shallow Breathing Index (RSBI) Change 30 days To determine change in Rapid Shallow Breathing Index (RSBI) from randomization to last available measure in subjects randomized to Treatment as compared to Control.
Mortality 30 days To compare Treatment (Lungpacer DPTS) subjects to Control subjects for mortality through Day 30.
Trial Locations
- Locations (33)
Lahey Hospital and Medical Center
🇺🇸Burlington, Massachusetts, United States
Universitätsmedizin Greifswald
🇩🇪Greifswald, Mecklenburg-Vorpommern, Germany
U of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Edward Hines VA Hospital
🇺🇸Hines, Illinois, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
CHU Angers
🇫🇷Angers, France
Indiana University Health Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
University of Texas Southwestern, Zale Lipshy Hospital
🇺🇸Dallas, Texas, United States
FKKG Schmallenberg
🇩🇪Schmallenberg, Germany
CHU Montpellier
🇫🇷Montpellier, France
KEM Essen
🇩🇪Essen, Germany
CHU Strasbourg
🇫🇷Strasbourg, France
SLK Löwenstein
🇩🇪Löwenstein, Germany
Nürnberg Klinikum Nord
🇩🇪Nürnberg, Germany
Solingen Krankenhaus Bethanien
🇩🇪Solingen, Germany
University of Utah
🇺🇸Salt Lake City, Utah, United States
Berlin Charite Mitte
🇩🇪Berlin, Germany
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
CHI Health Creighton University Medical Center - Bergan Mercy
🇺🇸Omaha, Nebraska, United States
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
University of Florida, Shands
🇺🇸Gainesville, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Englewood Hospital Medical Center
🇺🇸Englewood, New Jersey, United States
Kent County Memorial Hospital
🇺🇸Warwick, Rhode Island, United States
Prisma Health Baptist Hospital
🇺🇸Columbia, South Carolina, United States
Hôpital La Pitié-Salpêtrière
🇫🇷Paris, France