The goal of this study is to validate design for the Resolve™ Stimulator and Proximity Electrode and the associated procedure to quickly and safely place an electrode into the neck, in the vicinity of the vagus nerve by a physician in either the Emergency Department or other appropriate hospital inpatient setting (e.g., ICU). The secondary goal is to confirm that the electrical signal being delivered via this electrode rapidly counters bronchoconstriction and improves airway flow.
The present study is to evaluate the safety of a new neurostimulator device, the Resolve Stimulator and Proximity Lead™, which comprises an external electrical signal generator coupled to temporary electrode that is percutaneously inserted in the neck. Sponsor believes, based on animal testing data provided as well as consultations with physicians who regularly treat patients suffering from attacks of acute bronchoconstriction in ER and inpatient hospital settings, that this device could be used in the skilled care hospital setting to help rapidly relax the smooth muscle in the airway, relieving a clinically significant portion of the bronchoconstriction suffered by patients experiencing moderate to severe asthma attacks, allowing more effective delivery of inhaled medications to restore the patient to his or her baseline respiration status.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation
Rush University Medical Center
Chicago, Illinois, United States
Henry Ford Health System
Detroit, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Safety- Number of Participants With Adverse Events
Safety- Number of participants that reported Adverse Events
Time frame: 2 weeks
Improvement of Common Measures of Breathing Performance, Forced Expiry Volume in 1second (FEV1).
An assessment of Forced Expiry Volume in 1second (FEV1) measurements were taken throughout the course of treatment (15,30 and 60 minutes). Peak FEV1 measurements were recorded for each subject, and the number of minutes the subject had received treatment at the time of peak FEV1. The threshold for improvement was set at 12% over baseline at any of the time points (15,30 and 60 minutes). Outcome measure data indicates the number of subjects above 12%.
Time frame: 60 minutes
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Washington University School of Medicine, Barnes-Jewish Hospital,
St Louis, Missouri, United States
Dorrington Medical Associates
Houston, Texas, United States