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

1. Is over the age of 35 years

2. Has a history of COPD confirmed by physician diagnosis

3. Has been admitted to the hospital with a working diagnosis of acute exacerbation of COPD (AECOPD) defined as at least two of the following progressive symptoms: increased dyspnea, increased sputum volume and/or increased sputum purulence that is beyond normal day-to-day variation

4. Has a history of incomplete airway reversibility (e.g., patient not responding clinically to short-acting ß-agonists in the ED) associated with a diagnosis of COPD

5. Smoking history of at least 20 pack years

6. FEV1/FVC ratio of < 0.7 and impaired FEV1 (< 80% predicted for age, sex, race and height)

7. Is willing to participate in a 7 days post discharge (± 2 days) in-person follow-up visit and a telephone follow-up call 30 days (± 5 days) after hospital discharge

8. Is able to give written Informed Consent, or his/her legally authorized representative is available to give written Informed Consent

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):

4. Is admitted to the emergency care facility with a working diagnosis of:

5. Is admitted to the emergency care facility and/or hospital with a working diagnosis of:

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:

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)