A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning From Mechanical Ventilation
Stopped early · Not applicable
Conditions studied: Ventilator Induced Diaphragm Dysfunction
In brief
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.
Key facts
- Study ID
- NCT03783884
- Run by
- Lungpacer Medical Inc.
- People needed
- 223
- Starts
- 2019-06-14
- Expected to finish
- 2023-01-27
- Last updated by the study team
- 2024-12-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Temple University Hospital — Philadelphia, Pennsylvania, United States
- Kent County Memorial Hospital — Warwick, Rhode Island, United States
- Prisma Health Baptist Hospital — Columbia, South Carolina, United States
- University of Texas Southwestern, Zale Lipshy Hospital — Dallas, Texas, United States
- University of Utah — Salt Lake City, Utah, United States
- CHU Angers — Angers, France
- CHU Montpellier — Montpellier, France
- Hôpital La Pitié-Salpêtrière — Paris, France
- CHU Strasbourg — Strasbourg, France
- Universitätsmedizin Greifswald — Greifswald, Mecklenburg-Vorpommern, Germany
- Berlin Charite Mitte — Berlin, Germany
- KEM Essen — Essen, Germany
- SLK Löwenstein — Löwenstein, Germany
- Nürnberg Klinikum Nord — Nuremberg, Germany
- FKKG Schmallenberg — Schmallenberg, Germany
- Solingen Krankenhaus Bethanien — Solingen, Germany
- 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
- 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
Full record on ClinicalTrials.gov
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