Purpose

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 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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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 (of which one was the protocol-specific Ventilator Liberation Trial).

Exclusion Criteria

  1. maximal Inspiratory Pressure (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 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. body mass index (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. currently being treated in another clinical trial studying an experimental treatment that could affect the study primary outcome.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
1:1 randomization of treatment and control group
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Treatment
Subject receives Lungpacer LIVE Catheter insertion for transvenous phrenic nerve stimulation to deliver Diaphragm Pacing Therapy Sessions. DPT sessions are 6 sets of 10, delivered twice daily, for a total of 120 stimulation reps per day, plus standard of care for weaning from mechanical ventilation.
  • Device: Diaphragm Pacing Therapy
    Transvenous phrenic nerve stimulation to induce diaphragm contraction.
    Other names:
    • DPTS
No Intervention
Control
Subject does not receive Lungpacer LIVE Catheter or DPTS. Subject receives only Standard of care for weaning from mechanical ventilation.

Recruiting Locations

University of Maryland
Baltimore, Maryland 21201
Contact:
LaToya Stubbs
410-328-9951
lstubbs@som.umaryland.edu

More Details

NCT ID
NCT03783884
Status
Recruiting
Sponsor
Lungpacer Medical Inc.

Study Contact

Linda Clark
512-633-7077
lclark@lungpacer.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.