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A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning From Mechanical Ventilation (RESCUE3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03783884
Recruitment Status : Recruiting
First Posted : December 21, 2018
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Lungpacer Medical Inc.

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 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 or disease Intervention/treatment Phase
Ventilator Induced Diaphragm Dysfunction Device: Diaphragm Pacing Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 376 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 randomization of treatment and control group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : June 14, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : February 28, 2022

Arm Intervention/treatment
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 Name: DPTS

No Intervention: Control
Subject does not receive Lungpacer LIVE Catheter or DPTS. Subject receives only Standard of care for weaning from mechanical ventilation.



Primary Outcome Measures :
  1. Successful wean [ 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.

  2. Maximal Inspiratory Pressure mean change [ Time Frame: 30 days ]
    The MIP mean change from baseline will be statistically significantly greater for subjects randomized to Lungpacer DPTS compared to subjects randomized to Control.


Secondary Outcome Measures :
  1. Change in Rapid Shallow Breathing Index (RSBI) [ Time Frame: 30 days ]
    Change in RSBI over time from randomization (baseline)

  2. 30 day mortality [ Time Frame: 30 days ]
    To compare Treatment (Lungpacer DPTS) subjects to Control subjects for Day 30 mortality.

  3. Rate of RSBI change [ Time Frame: 30 days ]
    Rate of RSBI change per day from randomization (baseline) to last available measure

  4. Rate of MIP change [ Time Frame: 30 days ]
    Rate of MIP change per day from randomization (baseline) to last available measure;

  5. Change in MIP [ Time Frame: 30 days ]
    Change in MIP over time from randomization (baseline)

  6. Days on MV [ Time Frame: successful weaning or day 30 ]
    Days on mechanical ventilation from Day 1 to removal from MV associated with successful weaning or Day 30, whichever comes first.


Other Outcome Measures:
  1. Adverse event assessment [ Time Frame: 30 days ]
    Adverse events for subjects randomized to Treatment (Lungpacer DPTS) as compared to subjects randomized to Control.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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 neurologic, 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 ≥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. Bacteremia 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03783884


Contacts
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Contact: Sara Hill (484) 658-3390 shill@lungpacer.com
Contact: Linda Clark, RN 5126337077 lclark@lungpacer.com

Locations
Show Show 31 study locations
Sponsors and Collaborators
Lungpacer Medical Inc.
Investigators
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Study Director: Linda Clark Vice President of Clinical Affairs
Additional Information:
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Responsible Party: Lungpacer Medical Inc.
ClinicalTrials.gov Identifier: NCT03783884    
Other Study ID Numbers: P-300
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only investigators participating in this clinical trial will be able to see final de-identified participant data at the completion of the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Lungpacer Medical Inc.:
VIDD
Diaphragm Atrophy
Weaning Failure
VLT
SBT
VILI
Phrenic nerve stimulation
Maximal Inspiratory Pressure