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Using phrenic nerve stimulation to help patients wean off mechanical ventilation

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

Not applicable Interventional Stimdia Medical Inc. · NCT05998018

This study is testing if a new device that stimulates the phrenic nerve can help patients who have been on mechanical ventilation for a while to breathe on their own again.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment420 (estimated)
Ages18 Years and up
SexAll
SponsorStimdia Medical Inc. Industry-sponsored
Drugs / interventionsradiation
Locations21 sites (Mobile, Alabama and 20 other locations)
Trial IDNCT05998018 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of the pdSTIM System, which stimulates the phrenic nerve to assist patients in weaning off mechanical ventilation. Participants must have been on mechanical ventilation for at least four days and have previously failed a weaning attempt. The study involves randomizing subjects into two groups: one receiving standard care with the pdSTIM System and the other receiving standard care alone. The primary focus is on the time taken to wean off ventilation and the rates of serious adverse events between the two groups.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have been on mechanical ventilation for at least four days and have failed at least one weaning attempt.

Not a fit: Patients who have been on mechanical ventilation for more than 45 days or have pre-existing neurological or neuromuscular conditions affecting respiratory muscles will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the time patients spend on mechanical ventilation, improving recovery outcomes.

How similar studies have performed: While the specific use of the pdSTIM System is novel, similar approaches using nerve stimulation for respiratory support have shown promise in other studies.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Mobile, Alabama and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ventilator Induced Diaphragm DysfunctionMechanical VentilationPhrenic Nerve Stimulation
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.