Randomized Study of the pdSTIMâ„¢ System in Failure to Wean Mechanically Ventilated Patients (NCT05998018) | Clinical Trial Compass
TerminatedNot Applicable
Randomized Study of the pdSTIMâ„¢ System in Failure to Wean Mechanically Ventilated Patients
Stopped: Stopped due to a business decision
United States60 participantsStarted 2023-09-29
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject is 18 years or older.
✓. 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.
✓. Subject has been on mechanical ventilation for ≥ 96 hours prior to randomization (intubation or tracheostomy).
✓. Subject has failed at least 1 weaning attempt (e.g., site directed spontaneous breathing trial(s) did not result in liberation).
✓. 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
✕. Subject has been on invasive mechanical ventilation for \> 45 days.
✕. 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).
✕
What they're measuring
1
Time to Wean
Timeframe: Following completion of the 30-day follow-up by all available randomized subjects
2
Assessment of Serious Adverse Events (SAEs)
Timeframe: Following completion of the 30-day follow-up by all available randomized subjects
. 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.
✕. 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).
✕. 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).
✕. 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.
✕. 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.
✕. Subject has a local infection at or around the proposed pdSTIM Lead insertion site.