Vagus Nerve Stimulation for Management of Bronchoconstriction in Patients Hospitalized With COPD Exacerbations
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|ClinicalTrials.gov Identifier: NCT01612793|
Recruitment Status : Terminated
First Posted : June 6, 2012
Results First Posted : February 28, 2019
Last Update Posted : February 28, 2019
|Condition or disease||Intervention/treatment|
|Chronic Obstructive Pulmonary Disease||Device: AlphaCore Device|
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.
|Study Type :||Observational|
|Actual Enrollment :||4 participants|
|Official Title:||Non-Invasive Vagus Nerve Stimulation With the AlphaCore Device for Management of Bronchoconstriction in Patients Hospitalized With COPD|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
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
- Change in the Length of Stay in the Hospital [ Time Frame: Admission to hospital, 1 week in-person visit and a 30 day phone call follow-up visit from time of discharge from the hosptal ]The primary outcome measure was hospital length of stay (LOS) defined as the number of days from hospital admission to the date the subject met the medical elements of the GOLD Discharge Criteria. (Global Initiative for Chronic Obstructive Lung Disease report, "Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease", Revised 2011)
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01612793
|Edmonton, Alberta, Canada, T6G,2B7|
|Principal Investigator:||Brian Rowe, M.D.||University of Alberta|