Clinical trial NCT03783884: A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning From Mechanical Ventilation
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ventilator Induced Diaphragm Dysfunction
Keywords: VIDD
Diaphragm Atrophy
Weaning Failure
VLT
SBT
VILI
Phrenic Nerve Stimulation
Maximal Inspiratory Pressure
Lead sponsor: Lungpacer Medical Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-21
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization of treatment and control group
Primary purpose: TREATMENT

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.

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.

Eligibility 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 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.

Primary outcomes:
measure: Successful Weaning
timeFrame: 30 days
measure: Adverse Event Profile
timeFrame: 30 days
Secondary outcomes:
measure: Days on MV
timeFrame: Successful weaning or Day 30
measure: Maximal Inspiratory Pressure (MIP) Change
timeFrame: 30 days
measure: Rapid Shallow Breathing Index (RSBI) Change
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
Other outcomes:
measure: Time to first successful Ventilator Liberation Trial (VLT) after randomization
timeFrame: Successful VLT or 30 days
measure: Cessations and re-instatements of MV through Day 30 or study exit.
timeFrame: 30 days
measure: Tracheotomy after randomization
timeFrame: 30 days
measure: Change in ventilator settings
timeFrame: 30 days
measure: ICU admissions and discharges to Day 30.
timeFrame: 30 days
measure: Hospital admissions and discharges to Day 30.
timeFrame: 30 days
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Gainesville
country: United States
facility: University of Florida, Shands
state: Florida
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: U of Illinois at Chicago
state: Illinois
city: Hines
country: United States
facility: Edward Hines VA Hospital
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health Methodist Hospital
state: Indiana
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Burlington
country: United States
facility: Lahey Hospital and Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Omaha
country: United States
facility: CHI Health Creighton University Medical Center - Bergan Mercy
state: Nebraska
city: Englewood
country: United States
facility: Englewood Hospital Medical Center
state: New Jersey
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Warwick
country: United States
facility: Kent County Memorial Hospital
state: Rhode Island
city: Columbia
country: United States
facility: Prisma Health Baptist Hospital
state: South Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern, Zale Lipshy Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Angers
country: France
facility: CHU Angers
city: Montpellier
country: France
facility: CHU Montpellier
city: Paris
country: France
facility: Hôpital La Pitié-Salpêtrière
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald
state: Mecklenburg-Vorpommern
city: Berlin
country: Germany
facility: Berlin Charite Mitte
city: Essen
country: Germany
facility: KEM Essen
city: Löwenstein
country: Germany
facility: SLK Löwenstein
city: Nürnberg
country: Germany
facility: Nürnberg Klinikum Nord
city: Schmallenberg
country: Germany
facility: FKKG Schmallenberg
city: Solingen
country: Germany
facility: Solingen Krankenhaus Bethanien
Study officials:
References: