Vagus Nerve Stimulation for Management of Bronchoconstriction in Patients Hospitalized With COPD Exacerbations
Vagus Nerve Stimulation for Management of Bronchoconstriction in Patients Hospitalized With COPD Exacerbations
This study will look at the safety, improving symptoms and decreasing the length of stay of
 patients admitted to the hospital with COPD.
The primary safety measurement for this study is the type, occurrence and severity of adverse
 events (anticipated and unanticipated), including serious and non-serious device-related
 events.

 The primary outcome measure is hospital length of stay (LOS) defined as the number of days
 from hospital admission to the date the subject meets the medical elements of the GOLD
 Discharge Criteria.
Inclusion Criteria:

 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

 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)