Ventilator Induced Diaphragm Dysfunction
Conditions
Keywords
VIDD, Diaphragm Atrophy, Weaning Failure, VLT, SBT, VILI, Phrenic Nerve Stimulation, Maximal Inspiratory Pressure
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.
Interventions
Transvenous phrenic nerve stimulation to induce diaphragm contraction.
Sponsors
Lungpacer Medical Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1:1 randomization of treatment and control group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Are 18 years or older, and, 2. Have been mechanically ventilated for ≥96 hours (4 days), and, 3. Have satisfied the Readiness-to-Wean criteria, and, 4. 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
1. MIP (absolute value) \>50 cm H2O; 2. Invasive mechanical ventilation \>90 days; 3. Currently on ECMO; 4. Weaning failure due to hypervolemia; 5. Medical history (including imaging) or known anatomy that prevents percutaneous insertion of the Catheter into the intended thoracic vein on the left side. 6. Clinically overt congestive heart failure that is preventing weaning; 7. Currently being treated with neuromuscular blockade; 8. Pre-existing neurological, neuromuscular or muscular disorder that could affect the respiratory muscles; 9. Pre-existing severe chronic pulmonary fibrosis; 10. Pleural effusions occupying greater than one third of the pleural space on either side; 11. BMI \>45 kg/m2; 12. Known or suspected phrenic nerve paralysis; 13. 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; 14. Current hemodynamic instability, sepsis or septic shock; 15. Prior bacteremia reported within the last 48 hours; 16. Anticipating withdrawal of life support and/or shift to palliation as the goal of care; 17. Known or suspected to be pregnant or lactating; 18. Currently being treated in another clinical trial studying an experimental treatment that could affect the study primary outcome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to first successful Ventilator Liberation Trial (VLT) after randomization | Successful VLT or 30 days | Assessment of time to first successful VLT in the Treatment group as compared to the Control group. |
| Cessations and re-instatements of MV through Day 30 or study exit. | 30 days | Assessment of cessations and re-instatements of MV (e.g., reintubation) through Day 30 in the Treatment group as compared to the Control group. |
| Tracheotomy after randomization | 30 days | Assessment of proportion of subjects tracheotomized from randomization (baseline) to Day 30 in the Treatment group as compared to the Control group. |
| Change in ventilator settings | 30 days | Assessment of ventilator settings from baseline to last available measure in the Treatment group as compared to the Control group. |
| ICU admissions and discharges to Day 30. | 30 days | Assessment of ICU admissions and discharges to Day 30 in the Treatment group as compared to the Control group. |
| Hospital admissions and discharges to Day 30. | 30 days | Assessment of hospital admissions and discharges to Day 30 in the Treatment group as compared to the Control group. |
Countries
France, Germany, United States
Outcome results
None listed