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

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.

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.

Study Overview

• Status: Terminated
• Conditions: Ventilator Induced Diaphragm Dysfunction
• Intervention / Treatment: Device: Lungpacer Diaphragm Pacing Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 223
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • CHU Angers
  • Montpellier, France, 34295
    • CHU Montpellier
  • Paris, France, 75651
    • Hôpital La Pitié-Salpétrière
  • Strasbourg, France, 67091
    • CHU Strasbourg
• Germany
  • Berlin, Germany, 10117
    • Berlin Charite Mitte
  • Essen, Germany, 45276
    • KEM Essen
  • Löwenstein, Germany, 74245
    • SLK Löwenstein
  • Nürnberg, Germany, 90419
    • Nürnberg Klinikum Nord
  • Schmallenberg, Germany, 57392
    • FKKG Schmallenberg
  • Solingen, Germany, 42699
    • Solingen Krankenhaus Bethanien
  • Mecklenburg-Vorpommern
    • Greifswald, Mecklenburg-Vorpommern, Germany, 17475
      • Universitätsmedizin Greifswald
• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of COlorado Anschutz Medical Campus
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida, Shands
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine
    • Chicago, Illinois, United States, 60612
      • U of Illinois at Chicago
    • Hines, Illinois, United States, 60141
      • Edward Hines VA Hospital
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health Methodist Hospital
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Hospital and Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute Foundation
  • Nebraska
    • Omaha, Nebraska, United States, 68124
      • CHI Health Creighton University Medical Center - Bergan Mercy
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Englewood Hospital Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Kent County Memorial Hospital
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Prisma Health Baptist Hospital
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern, Zale Lipshy Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Treatment; Subject receives Lungpacer Catheter 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: Lungpacer Diaphragm Pacing Therapy; Transvenous phrenic nerve stimulation to induce diaphragm contraction.; Other Names: Lungpacer DPTS; AeroPace System
NO_INTERVENTION: Control; Subject does not receive Lungpacer Catheter or DPT. Subject receives only Standard of care for weaning from mechanical ventilation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful wean	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.	30 days
Maximal Inspiratory Pressure mean change	The MIP mean change from baseline will be statistically significantly greater for subjects randomized to Lungpacer DPTS compared to subjects randomized to Control.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Rapid Shallow Breathing Index (RSBI)	Change in RSBI over time from randomization (baseline)	30 days
Mortality	To compare Treatment (Lungpacer DPTS) subjects to Control subjects for Day 30 mortality.	30 days
Rate of RSBI Change	Rate of RSBI change per day from randomization (baseline) to last available measure	30 days
Rate of MIP Change	Rate of MIP change per day from randomization (baseline) to last available measure;	30 days
Change in MIP	Change in MIP over time from randomization (baseline)	30 days
Days on MV	Days on mechanical ventilation from Day 1 to removal from MV associated with successful weaning or Day 30, whichever comes first.	Successful weaning or day 30

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event Assessment	Adverse events for subjects randomized to Treatment (Lungpacer DPTS) as compared to subjects randomized to Control.	30 days

Collaborators and Investigators

• Sponsor: Lungpacer Medical Inc.

Publications and helpful links

Helpful Links

• Sponsor website

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 14, 2019
• Primary Completion (ACTUAL): December 28, 2022
• Study Completion (ACTUAL): January 27, 2023

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: December 19, 2018
• First Posted (ACTUAL): December 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: VIDD; VILI; SBT; Maximal Inspiratory Pressure; Weaning Failure; Diaphragm Atrophy; VLT; Phrenic Nerve Stimulation
• Other Study ID Numbers: P-300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes