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

NCT03783884 | Terminated DMC FDA Device

• 1 other identifier: P-300
• Study Type: interventional
• Target: 223
• Locations: 3 countries
• Sites: 33

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 have 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.

Conditions

Ventilator Induced Diaphragm Dysfunction

Keywords

VIDD; Diaphragm Atrophy; Weaning Failure; VLT; SBT; VILI; Phrenic Nerve Stimulation; Maximal Inspiratory Pressure

Outcome Measures

Primary Outcomes (2)

• Successful Weaning

  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

• Adverse Event Profile

  Characterize the adverse event profile to support an observed consistent risk profile for subjects randomized to Treatment compared to subjects randomized to Control.

  30 days

Secondary Outcomes (4)

• Days on MV

  Successful weaning or Day 30

• Maximal Inspiratory Pressure (MIP) Change

  30 days

• Rapid Shallow Breathing Index (RSBI) Change

  30 days

• Mortality

  30 days

Other Outcomes (6)

• Time to first successful Ventilator Liberation Trial (VLT) after randomization

  Successful VLT or 30 days

• Cessations and re-instatements of MV through Day 30 or study exit.

  30 days

• Tracheotomy after randomization

  30 days

Study Arms (2)

Treatment

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

Subject does not receive Lungpacer Catheter or DPT. Subject receives only Standard of care for weaning from mechanical ventilation.

Interventions

Lungpacer Diaphragm Pacing Therapy DEVICE

Transvenous phrenic nerve stimulation to induce diaphragm contraction.

Also known as: Lungpacer DPTS, AeroPace System

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are 18 years or older, and,
• Have been mechanically ventilated for ≥96 hours (4 days), and,
• Have satisfied the Readiness-to-Wean criteria, and,
• 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).

You may not qualify if:

• MIP (absolute value) \>50 cm H2O;
• Invasive mechanical ventilation \>90 days;
• Currently on ECMO;
• Weaning failure due to hypervolemia;
• Medical history (including imaging) or known anatomy that prevents percutaneous insertion of the Catheter into the intended thoracic vein on the left side.
• Clinically overt congestive heart failure that is preventing weaning;
• Currently being treated with neuromuscular blockade;
• Pre-existing neurological, neuromuscular or muscular disorder that could affect the respiratory muscles;
• Pre-existing severe chronic pulmonary fibrosis;
• Pleural effusions occupying greater than one third of the pleural space on either side;
• BMI \>45 kg/m2;
• Known or suspected phrenic nerve paralysis;
• 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;
• Current hemodynamic instability, sepsis or septic shock;
• Prior bacteremia reported within the last 48 hours;

Sponsors & Collaborators

• Lungpacer Medical Inc.: lead

Study Sites (33)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

University of Florida, Shands

Gainesville, Florida, 32610, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

U of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Edward Hines VA Hospital

Hines, Illinois, 60141, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

CHI Health Creighton University Medical Center - Bergan Mercy

Omaha, Nebraska, 68124, United States

Location

Englewood Hospital Medical Center

Englewood, New Jersey, 07631, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Kent County Memorial Hospital

Warwick, Rhode Island, 02886, United States

Location

Prisma Health Baptist Hospital

Columbia, South Carolina, 29203, United States

Location

University of Texas Southwestern, Zale Lipshy Hospital

Dallas, Texas, 75390, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

CHU Angers

Angers, 49933, France

Location

CHU Montpellier

Montpellier, 34295, France

Location

Hôpital La Pitié-Salpêtrière

Paris, 75651, France

Location

CHU Strasbourg

Strasbourg, 67091, France

Location

Universitätsmedizin Greifswald

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Location

Berlin Charite Mitte

Berlin, 10117, Germany

Location

KEM Essen

Essen, 45276, Germany

Location

SLK Löwenstein

Löwenstein, 74245, Germany

Location

Nürnberg Klinikum Nord

Nuremberg, 90419, Germany

Location

FKKG Schmallenberg

Schmallenberg, 57392, Germany

Location

Solingen Krankenhaus Bethanien

Solingen, 42699, Germany

Location

Related Publications (1)

• Dres M, Ewert R, Conrad SA, Ataya A, Shrager J, Mortaza S, Delamaire F, Nilius G, Heine A, Mehta N, Ways J, Evans D, Paulon G, Khandwala F, Berry N, Viele K, Nelson T, Gilbertson M, Similowski T, Gama de Abreu M, Goligher EC; RESCUE-3 Trial Investigators. Temporary Transvenous Diaphragm Neurostimulation for Weaning from Mechanical Ventilation (RESCUE-3). Am J Respir Crit Care Med. 2025 Jun 11. doi: 10.1164/rccm.202505-1056OC. Online ahead of print.

  PMID: 40498082 DERIVED

Related Links

• Sponsor website

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1:1 randomization of treatment and control group

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 21, 2018
• Study Start: June 14, 2019
• Primary Completion: December 28, 2022
• Study Completion: January 27, 2023
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (7); FR (4); US (22)