Randomized Study of the pdSTIM™ System (Phrenic Nerve to Diaphragm STIMulation) in Failure to Wean Mechanically Ventilated Patients
NCT ID: NCT05998018
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
420 participants
INTERVENTIONAL
2023-09-29
2026-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The primary endpoints focus on time to weaning and serious adverse event rates between the Treatment and Control groups.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing
NCT03096639
Pivotal Evaluation of Abdominal Neuromuscular Electrical Stimulation (VentFree) for Weaning From Mechanical Ventilation
NCT05759013
Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing (RESCUE1)
NCT03107949
Electrical Phrenic Nerve Stimulation in Patients With VIDD
NCT06436950
STimulation to Activate RespIration
NCT06832306
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
pdSTIM System Therapy
pdSTIM System Therapy
Stimulate the phrenic nerves in synchrony with inspiratory cycles of the ventilator which exercises the diaphragm
Standard of Care
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
pdSTIM System Therapy
Stimulate the phrenic nerves in synchrony with inspiratory cycles of the ventilator which exercises the diaphragm
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
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.
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Stimdia Medical Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Steven Conrad, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
LSU Health Sciences Shreveport
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of South Alabama
Mobile, Alabama, United States
Chandler Regional Medical Center
Chandler, Arizona, United States
Abrazo West Health
Goodyear, Arizona, United States
HonorHealth Research Institute
Scottsdale, Arizona, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
University of Illinois Chicago
Chicago, Illinois, United States
RML Specialty Hospital
Hinsdale, Illinois, United States
University of Louisville
Louisville, Kentucky, United States
Tulane University Medical Center
New Orleans, Louisiana, United States
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, United States
University of Michigan Health - West
Wyoming, Michigan, United States
Bryan Medical Center
Lincoln, Nebraska, United States
Northwell South Shore University Hospital
Bay Shore, New York, United States
University at Buffalo
Buffalo, New York, United States
Atrium Health
Charlotte, North Carolina, United States
WakeMed Health
Raleigh, North Carolina, United States
Forsyth Medical Center
Winston-Salem, North Carolina, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Baptist Clinical Research Institute, Inc.
Memphis, Tennessee, United States
St. David's Healthcare
Georgetown, Texas, United States
Houston Methodist
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Schaaf K, Mullin CM, Cunningham KW, Eaton J, Conrad SA. The ReInvigorate Study-phrenic nerve-to-diaphragm stimulation for weaning from mechanical ventilation: a protocol for a randomized pivotal clinical trial. Trials. 2024 Aug 2;25(1):519. doi: 10.1186/s13063-024-08355-8.
Related Links
Access external resources that provide additional context or updates about the study.
Company Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CIP0002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.