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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Non-Invasive Vagus Nerve Stimulation With the AlphaCore Device for Management of Bronchoconstriction in Patients Hospitalized With COPD|
- Change in the Length of stay in the hospital [ Time Frame: Admission to hospital, 1 week in-person visit and a 30day phone call follow-up visit from time of discharge from the hosptil ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples Without DNA
Complete CBC and blood gases will be drawn at different time points to establish the medical condition of the subjects.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
AlphaCore device group will consist of subjects enrolled into the study with chronic obstructive pulmonary disease and receive an electrical stimulation to the vagus nerve to help open the subjects airways during the subjects stay in the hospital.
Device: AlphaCore Device
multiple stimulation treatments per day for duration of hospitalization
Other Name: Non-invasive vagus nerve stimulation
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.