A Randomized, Controlled, Open-labeled, Multi-center Clinical Trial to Evaluate the Safe and Effective Performance of the Lungpacer Diaphragm Pacing Therapy System in Patients Who Have Failed to Wean From Mechanical Ventilation.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ventilator Induced Diaphragm Dysfunction
- Sponsor
- Lungpacer Medical Inc.
- Enrollment
- 223
- Locations
- 33
- Primary Endpoint
- Successful Weaning
- Status
- Terminated
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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;
Outcomes
Primary Outcomes
Successful Weaning
Time Frame: 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
Time Frame: 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 Outcomes
- Days on MV(Successful weaning or Day 30)
- Maximal Inspiratory Pressure (MIP) Change(30 days)
- Rapid Shallow Breathing Index (RSBI) Change(30 days)
- Mortality(30 days)