Mechanical Ventilation Weaning, Neuromodulation, Phrenic Nerve Stimulation, Ventilator Induced Diaphragm Dysfunction
Conditions
Keywords
Mechanical Ventilation, Phrenic Nerve Stimulation, Neuromodulation
Brief 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.
Detailed 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.
Interventions
DEVICEpdSTIM System Therapy
Stimulate the phrenic nerves in synchrony with inspiratory cycles of the ventilator which exercises the diaphragm
Conventional medical management
Sponsors
Stimdia Medical Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Wean | Following completion of the 30-day follow-up by all available randomized subjects | Assess time to successful weaning from mechanical ventilation for the subjects randomized to Treatment as compared to subjects randomized to Control |
| Assessment of Serious Adverse Events (SAEs) | Following completion of the 30-day follow-up by all available randomized subjects | Assessment of Serious Adverse Events (SAEs) for the subjects randomized to Treatment as compared to subjects randomized to Control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality Rates | Following completion of the 30-day follow-up by all available randomized subjects | Compare 30-day mortality rates of Treatment and Control subjects |
| Adverse Event Rates | Following completion of the 30-day follow-up by all available randomized subjects | Compare adverse event rates for Treatment and Control subjects |
| Days on Mechanical Ventilation | Following completion of the 30-day follow-up by all available randomized subjects | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSteven Conrad, MD,PhD
LSU Health Sciences Shreveport
Outcome results
None listed