Chronic airway disease Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Intervention subjects will receive the vagal nerve stimulation three times a
day, according to the device instructions, starting on the first day following
admission, until the day of discharge, or
Sponsors
Medisch Spectrum Twente
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age > 40 years, male or female Ability to understand and read Dutch Diagnosis of COPD stage II, III or IV according to GOLD Hospitalised at ward A4 or C4 Is able to give written informed consent Borg score
Exclusion criteria
Exclusion criteria: Has an abscess or other infection or lesion (including lymphadenopathy) at the right side (treatment site) of the neck. Is currently implanted with an electrical and/or neurostimulator device, such as cardiac pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant). Subjects with metal implants including but not limited to stents, bone plates and bone screws, at or near the treatment area. Acquainted with known carotid artery stenosis Has a history of carotid endarterectomy or vascular neck surgery on the right side. Has a history of syncope or seizures during the last year. Brachycardia at rest
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Breathlessness, measured through the BORG scale from 0 (no breathlessness) until 10 (extreme breathlessness). Change in breathlessness, measured in hours. The patients have to fill in on a score form their BORG score every hour after each (sham) simulation with a maximum of five hours. Breathing frequency, in breaths per minute. Before and direct after the (sham) stimulation the investigator measures breathing frequency. Airway resistance, measured with Forced Oscillation Technique (FOT). Description of position of the vagal nerve, on the left and right side of the neck, through a one-time ultrasound examination. The number of times bronchodilating medication is administered. It is important to know whether subjects use less medication due to the vagus nerve stimulation. Adverse Events | — |
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the time to discharge. This will be measured in days from the day of admission. If a patient is admitted between 2400 h and 1200 h, the day of admission is counted as 1 day; if the patient is admitted after 1200 h, the day of admission is counted as 0.5 days. | — |
Countries
Netherlands
Outcome results
None listed