Ventilator Induced Diaphragm Dysfunction
Conditions
Keywords
VIDD, Diaphragm Atrophy, Weaning Failure, SBT, Phrenic Nerve Stimulation
Brief summary
A single-arm, prospective, multicenter cohort study to assess the 30-day continued safety and effectiveness of the AeroPace System in patients on mechanical ventilation (MV) at least 96 hours and who have not weaned. This is a study collecting real-world data in a post-market setting.
Interventions
Transvenous phrenic nerve stimulation to induce diaphragm contraction.
Sponsors
Lungpacer Medical Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Are 18 years or older, and, 2. Will have been mechanically ventilated for ≥96 hours (4 days) by the time of Catheter insertion, and, 3. Have not weaned from MV, and, 4. Have failed an institutional SBT within 48 hours of enrollment.
Exclusion criteria
1. Invasive mechanical ventilation \>90 days. 2. Currently on extracorporeal membrane oxygenation (ECMO). 3. Weaning failure due to hypervolemia. 4. Medical history (including imaging) or known anatomy that prevents percutaneous insertion of the Catheter into the intended thoracic vein on the left side. 5. Clinically overt congestive heart failure that is preventing weaning. 6. Currently being treated with neuromuscular blockade that could affect phrenic nerve / diaphragm contraction. 7. Pre-existing neurological, neuromuscular or muscular disorder that could affect the respiratory muscles. 8. Pre-existing severe chronic pulmonary fibrosis. 9. Known pleural effusions occupying greater than one third of the pleural space on either side. 10. BMI \>70 kg/m2. 11. Known or suspected phrenic nerve paralysis. 12. Any electrical device (implanted or external) that may be prone to interaction with, or interference from the AeroPace System, including neurological pacing/stimulator devices, cardiac pacemakers and defibrillators. 13. Current hemodynamic instability 14. Uncontrolled sepsis or septic shock. 15. Current or untreated bacteremia. 16. Expecting 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 |
|---|---|---|
| Adverse Event Profile | 30 days | All Serious Adverse Events from enrollment to study exit and device- and/or procedure-related Adverse Events until successful wean, withdrawal/death, transfer or day 30 (whichever comes first). |
| Successful Weaning | 30 days | Proportion of subjects successfully weaned by Day 30 |
Secondary
| Measure | Time frame |
|---|---|
| Days on mechanical ventilation from time of initial placement procedure through Day 30. | 30 days |
| Incidence of reintubation/reinstatement of MV through Day 30 | 30 days |
| Incidence of device/procedure related SAEs as compared to RESCUE 3 Treatment group subjects | 30 days |
| Mortality through Day 30 | 30 days |
| Incidence of tracheostomy from enrollment through Day 30 | 30 days |
| ICU/hospital days from initial placement procedure to Day 32 | 32 days |
Contacts
CONTACTMegan Cotts
CONTACTAERO-PAS Study
Outcome results
None listed