Status:
TERMINATED
A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning From Mechanical Ventilation
Lead Sponsor:
Lungpacer Medical Inc.
Conditions:
Ventilator Induced Diaphragm Dysfunction
Eligibility:
All Genders
18+ years
Phase:
NA
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 car...
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) ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
June 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2023
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT03783884
Start Date
June 14 2019
End Date
January 27 2023
Last Update
December 9 2024
Active Locations (33)
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1
Stanford University Medical Center
Stanford, California, United States, 94305
2
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
3
University of Florida, Shands
Gainesville, Florida, United States, 32610
4
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611