Randomized Study of the pdSTIM™ System (Phrenic Nerve to Diaphragm STIMulation) in Failure to Wean Mechanically Ventilated Patients

Ventilator Induced Diaphragm Dysfunction Clinical Trial

— ReInvigorate  

Official title:

Randomized Study of the pdSTIM™ System (Phrenic Nerve to Diaphragm STIMulation) in Failure to Wean Mechanically Ventilated Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05998018
• Other study ID #: CIP0002
• Status: Recruiting
• Phase: N/A
• Start date: September 29, 2023
• Est. completion date: February 28, 2026

Study information

• Verified date: June 2024
• Source: Stimdia Medical Inc.
• Contact: Head of Clinical
• Phone: 612-445-8252
• Email: clinical[@]stimdia.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective, multi-center, randomized, controlled clinical trial is being conducted to evaluate the safety and efficacy of the pdSTIM System to facilitate weaning from mechanical ventilation through phrenic nerve stimulation. Potential subjects who are on mechanical ventilation for at least four days and have failed at least one weaning attempt will be considered for the study. Those enrolled will be randomized in a 1:1 manner between the treatment group that is standard of care with the pdSTIM System and a Control group, which is standard of care alone.

The primary endpoints focus on time to weaning and serious adverse event rates between the Treatment and Control groups.

Description:

The pdSTIM Pivotal Study (ReInvigorate Study) is a prospective, multicenter, randomized, controlled clinical study to evaluate the safety and efficacy of the pdSTIM System to facilitate weaning from mechanical ventilation through phrenic nerve stimulation. Potential subjects who are on mechanical ventilation for ≥ 96 hours (4 days) and have failed at least one weaning attempt will be considered for the study.

Those enrolled will be randomized in a 1:1 manner between a Treatment group that is standard of care with the pdSTIM System and a Control group that is standard of care only. For the Treatment group, stimulation therapy with pdSTIM will occur daily until the subject is successfully removed from mechanical ventilation or the 30-Day follow-up visit, whichever is sooner. All randomized subjects will be followed to 60 (± 7) days post randomization. Total subject participation will be no longer than 67 days.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: February 28, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject is 18 years or older.

2. Subject, or subject's Legally Authorized Representative, understands study requirements, study visits, and is willing and able to provide written informed consent prior to study specific procedures or testing.

3. Subject has been on mechanical ventilation for = 96 hours prior to randomization (intubation or tracheostomy).

4. Subject has failed at least 1 weaning attempt (e.g., site directed spontaneous breathing trial(s) did not result in liberation).

5. At the time of enrollment, the subject is likely to be ventilated for an additional 48 hours, at minimum, in the opinion of the investigator.

Exclusion Criteria:

1. Subject has been on invasive mechanical ventilation for > 45 days.

2. Subject failed to wean due to pre-existing neurological or neuromuscular issues affecting the respiratory muscles (e.g., ALS, phrenic nerve paralysis, inflammatory muscle disease, underlying myopathy, myasthenia gravis, cervical spinal injury).

3. Subject's medical history, known anatomy or investigator's inability to visualize necessary anatomical landmarks that could prevent the safe placement of the pdSTIM leads.

4. Subject is at risk of significant hemorrhage or is currently receiving a full dose of systemic anticoagulation (e.g., IV heparin, high dose of subcutaneous heparin. Subjects on prophylactic anticoagulation or daily aspirin regimen on their own are not excluded unless other exclusion criteria apply).

5. Subject has an implant or external electrical device that may interact or interfere with the pdSTIM System (examples may include cardiac pacemaker, implantable defibrillator, vagal nerve stimulator, spinal cord stimulator, gastric stimulator, diaphragmatic stimulator).

6. Subject has been diagnosed and has been treated for neck cancer within the past 5 years or subject had any prior radiation treatment to the neck.

7. Subject currently has hemodynamic instability due to any cause (e.g., severe sepsis, hemorrhagic shock, or septic shock) with vasopressor support > 0.1 mg/kg/min of norepinephrine or epinephrine, or equivalent, or is actively being titrated.

8. Subject has a local infection at or around the proposed pdSTIM Lead insertion site.

9. Subject is neutropenic or has signs of significant immunocompromise. (Subjects intubated for respiratory failure due to COVID-19 are not excluded unless other exclusion criteria apply).

10. Subject has severe COPD as indicated by evidence of significant expiratory obstruction on the ventilator flow waveform or, where ventilator flow waveforms are not utilized, has a FEV1 = 30%.

11. Subject has pre-existing severe chronic pulmonary fibrosis.

12. Subject has pleural effusion occupying greater than 1/3 of the pleural space on either side.

13. Subject is currently on or expected to begin neuromuscular blockades.

14. Subject is anticipating withdrawal of life support and/or shift to palliation as the goal of care with less than 6-months life expectancy.

15. Subject is known or suspected to be pregnant or lactating.

16. Subject is currently enrolled in or exited early from a) any investigational drug study or b) an investigational device study that may impact the ability to wean or is directly related to the lungs or diaphragm.

Related Conditions & MeSH terms

• Ventilator Induced Diaphragm Dysfunction

Intervention

Device:
• pdSTIM System Therapy
Stimulate the phrenic nerves in synchrony with inspiratory cycles of the ventilator which exercises the diaphragm

Locations

Country	Name	City	State
United States	Northwell South Shore University Hospital	Bay Shore	New York
United States	University at Buffalo	Buffalo	New York
United States	Chandler Regional Medical Center	Chandler	Arizona
United States	Atrium Health	Charlotte	North Carolina
United States	University of Illinois Chicago	Chicago	Illinois
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	St. David's Healthcare	Georgetown	Texas
United States	Abrazo West Health	Goodyear	Arizona
United States	Houston Methodist	Houston	Texas
United States	Bryan Medical Center	Lincoln	Nebraska
United States	University of Louisville	Louisville	Kentucky
United States	University of South Alabama	Mobile	Alabama
United States	Tulane University Medical Center	New Orleans	Louisiana
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	WakeMed Health	Raleigh	North Carolina
United States	LSU Health Sciences Center at Shreveport	Shreveport	Louisiana
United States	Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Stimdia Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	pdSTIM System Summary	Summarize pdSTIM System characteristics, such as lead placement success rate, duration of procedure, waveforms of flow/pressure, and programmed parameters over time	Following completion of the 30-day follow-up by all available randomized subjects
Other	Mean Change in Rapid Shallow Breathing Index (RSBI)	Compare the mean change in Rapid Shallow Breathing Index from randomization to Day 30 or removal of mechanical ventilation, whichever comes first, for Treatment and Control subjects	Following completion of the 30-day follow-up by all available randomized subjects
Other	Number of ICU Days	Compare the number of ICU days from randomization to Day 30 or removal of mechanical ventilation, whichever comes first, for Treatment and Control subjects	Following completion of the 30-day follow-up by all available randomized subjects
Other	Rate of Re-intubation	Compare the rate of re-intubation following successful weaning for Treatment and Control subjects	Following completion of the 30-day follow-up by all available randomized subjects
Primary	Time to Wean	Assess time to successful weaning from mechanical ventilation for the subjects randomized to Treatment as compared to subjects randomized to Control	Following completion of the 30-day follow-up by all available randomized subjects
Primary	Assessment of Serious Adverse Events (SAEs)	Assessment of Serious Adverse Events (SAEs) for the subjects randomized to Treatment as compared to subjects randomized to Control	Following completion of the 30-day follow-up by all available randomized subjects
Secondary	Mortality Rates	Compare 30-day mortality rates of Treatment and Control subjects	Following completion of the 30-day follow-up by all available randomized subjects
Secondary	Adverse Event Rates	Compare adverse event rates for Treatment and Control subjects	Following completion of the 30-day follow-up by all available randomized subjects
Secondary	Days on Mechanical Ventilation	Compare number of days on mechanical ventilation from the date of randomization to removal of mechanical ventilation associated with successful weaning or Day 30, whichever comes first, for Treatment and Control subjects	Following completion of the 30-day follow-up by all available randomized subjects

External Links

•   Company Website