A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning From Mechanical Ventilation

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.

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 (of which one was the protocol-specific
Ventilator Liberation Trial).

Exclusion Criteria:

1. MIP (absolute value) >50 cm H2O;

2. Invasive mechanical ventilation >45 days;

3. currently on ECMO;

4. weaning failure due to hypervolemia;

5. medical history (including imaging) or known anatomy that prevents insertion of LIVE
Catheter into the Left Subclavian vein;

6. clinically overt congestive heart failure that is preventing weaning;

7. currently being treated with neuromuscular blockade;

8. pre-existing neuromuscular or muscular dissorder 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 ≥ 40;

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 within the last 48 hours;

16. terminally ill with 6 months or less of life expectancy or not committed to full care;

17. known or suspected to be pregnant or lactating;

18. treatment with an investigational device or drug within 30 days of enrollment.