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

Ventilator Induced Diaphragm Dysfunction Clinical Trial

— RESCUE3  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03783884
• Other study ID #: P-300
• Status: Terminated
• Phase: N/A
• Start date: June 14, 2019
• Est. completion date: January 27, 2023

Study information

• Verified date: February 2023
• Source: Lungpacer Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 223
• Est. completion date: January 27, 2023
• Est. primary completion date: December 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ventilator Induced Diaphragm Dysfunction

Intervention

Device:
• Lungpacer Diaphragm Pacing Therapy
Transvenous phrenic nerve stimulation to induce diaphragm contraction.

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHU Montpellier	Montpellier
France	Hôpital La Pitié-Salpêtrière	Paris
France	CHU Strasbourg	Strasbourg
Germany	Berlin Charite Mitte	Berlin
Germany	KEM Essen	Essen
Germany	Universitätsmedizin Greifswald	Greifswald	Mecklenburg-Vorpommern
Germany	SLK Löwenstein	Löwenstein
Germany	Nürnberg Klinikum Nord	Nürnberg
Germany	FKKG Schmallenberg	Schmallenberg
Germany	Solingen Krankenhaus Bethanien	Solingen
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	Lahey Hospital and Medical Center	Burlington	Massachusetts
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	U of Illinois at Chicago	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Prisma Health Baptist Hospital	Columbia	South Carolina
United States	Ohio State University	Columbus	Ohio
United States	University of Texas Southwestern, Zale Lipshy Hospital	Dallas	Texas
United States	Englewood Hospital Medical Center	Englewood	New Jersey
United States	University of Florida, Shands	Gainesville	Florida
United States	Edward Hines VA Hospital	Hines	Illinois
United States	Indiana University Health Methodist Hospital	Indianapolis	Indiana
United States	University of Louisville	Louisville	Kentucky
United States	Loyola University Medical Center	Maywood	Illinois
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
United States	CHI Health Creighton University Medical Center - Bergan Mercy	Omaha	Nebraska
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	University of Utah	Salt Lake City	Utah
United States	Stanford University Medical Center	Stanford	California
United States	Kent County Memorial Hospital	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Lungpacer Medical Inc.

Countries where clinical trial is conducted

United States,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Event Assessment	Adverse events for subjects randomized to Treatment (Lungpacer DPTS) as compared to subjects randomized to Control.	30 days
Primary	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
Primary	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	Change in Rapid Shallow Breathing Index (RSBI)	Change in RSBI over time from randomization (baseline)	30 days
Secondary	Mortality	To compare Treatment (Lungpacer DPTS) subjects to Control subjects for Day 30 mortality.	30 days
Secondary	Rate of RSBI Change	Rate of RSBI change per day from randomization (baseline) to last available measure	30 days
Secondary	Rate of MIP Change	Rate of MIP change per day from randomization (baseline) to last available measure;	30 days
Secondary	Change in MIP	Change in MIP over time from randomization (baseline)	30 days
Secondary	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

External Links

•   Sponsor website