Vagus Nerve Stimulation for Management of Bronchoconstriction in Patients Hospitalized With COPD Exacerbations

Exclusion Criteria

• •1. Has a confirmed history of asthma (by pulmonary functions, response to ß-agonists and variable symptoms)
• •2. Has a history of lung cancer or Talc lung
• •3. Is admitted to the emergency care facility with a diagnosis of the following, confirmed on CXR, ventilation/perfusion scanning or computerized tomography (CT):
• •* Pulmonary abscess;
• •* Pneumonia (e.g., fever \> 38.0° C, cough and new documented infiltrate)
• •* Acute pulmonary embolism
• •* Large pleural effusion and/or requiring thoracentesis; or
• •* Pneumothorax
• •4. Is admitted to the emergency care facility with a working diagnosis of:
• •* Acute coronary syndrome
• •* Severe carotid artery disease (e.g., history of bruits, transient ischemic attack (TIA) or cerebrovascular accident (CVA); or
• •* Stage IV heart failure according to the NYHA classification
• •5. Is admitted to the emergency care facility and/or hospital with a working diagnosis of:
• •* Cystic Fibrosis; or
• •* Tuberculosis
• •* Pneumocystis carinii pneumonia (PCP) infection in the setting of HIV
• •6. Other severe cardiovascular acute diseases (such as uncontrolled hypertension, recent onset rapid atrial fibrillation and severe ventricular arrhythmias)
• •7. Is at risk of imminent respiratory collapse:
• •* Lung Function: FEV1 \< 25%
• •* Rapid deterioration in respiratory status (sudden change in respiratory rate, decrease in oxygen saturation, change in consciousness, etc).
• •8. Has a condition in which collecting blood would be contraindicated or blood samples are unable to be obtained;
• •9. Has an abscess or other infection, lesion (including lymphadenopathy), surgical scar, congenital changes or broken skin at the treatment site on the neck;
• •10. Has confirmed severe sepsis or septic shock
• •11. Has a fever \> 38.0° C
• •12. Has clinically significant changes in blood pressure or is receiving vasopressors to maintain blood pressure
• •13. Has an implanted electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, automated implantable cardioverter defibrillators (AICD), vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant
• •14. Has a history of carotid endarterectomy or vascular neck surgery on the right side
• •15. Has implanted metal cervical spine hardware
• •16. Has a condition that would interfere with completing the self-assessment questionnaires
• •17. Is pregnant or breast feeding
• •18. Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days
• •19. Belongs to a population or has any condition such that the investigator believes his or her ability to provide informed consent, comply with follow-up requirements or provide self-assessments is compromised (e.g., homeless, developmentally disabled, prisoner)