The AlphaCore* is currently being used in some hospitalised COPD subjects, as adjunctive treatment to regular care. This use is conform CE and is showing diminished breathlessness in some subjects. For further investigation of these results, this…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
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
Background summary
The main reason for subjects with COPD to be hospitalised is a COPD
exacerbation, which is accompanied by increased breathlessness. Standard
treatment options include oral prednisolon, antibiotics (oral or
intravenously), and bronchodilation. Discharge from the hospital is mainly
determined by the recovery from breathlessness. On average subjects remain
admitted for 8-9 days. When use of the AlphaCore* reduces breathlessness, it is
assumed that time to discharge is shortened.
Study objective
The AlphaCore* is currently being used in some hospitalised COPD subjects, as
adjunctive treatment to regular care. This use is conform CE and is showing
diminished breathlessness in some subjects. For further investigation of these
results, this new study is drafted. The outcomes of this study will provide
evidence of the effect of the AlphaCore* in COPD patient that are hospitalized
with an exacerbation.
To assess the effect of using the AlphaCore*, as adjunctive treatment to
regular care, on time to discharge in hospitalised subjects with COPD.
Study design
This study will be designed as a prospective balanced controlled trial. In the
intervention group the AlphaCore* will be used, as adjunctive treatment to
regular care. Subjects in the control group will receive regular care and sham
stimulation. When there is only one bed on one of the two wards, the pulmonary
physician has to assign the patient to this ward. Balancing (mininisation) is a
form of randomisation, and will be used when free beds are available on both
wards. With the help of the a minisation program, minim.exe, the potential
confounders (e.g. GOLD classification, age) will be balanced over both wards.
Balancing assigns patients to intervention or control ward, based on
distribution of all potential confounders thus far, in order to balance this
distribution.
Intervention
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 until day 10. The control subjects
will receive identical care, but with sham stimulation, twice daily.
Breathlessness will be recorded every 2 minutes for 16 minutes following each
AlphaCore or stimulation, and time to discharge will be recorded.
Study burden and risks
Vagal nerve stimulation is granted as save. Miner (2011) stated: *There were no
reported incidences of increased dyspnoea, nausea or vomiting noted. There is
no instance of nerve damage or suspected damage detected, except for rise of a
superficially hematoma in percutaneous placement of an electrode by vagal nerve
stimulation(1). The risk for adverse events due to participation in this study
is considered negligible.
1. Miner J, et al., Feasibility of percutaneous vagal electrical stimulation
for the treatment of acute asthma exacerbation, in SCCM*s 40th Critical Care
Congress, January 15-19. 2011: San Diego. Accepted.
Haaksbergerstraat 55
Enschede 7513ER
NL
Haaksbergerstraat 55
Enschede 7513ER
NL
Listed location countries
Age
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 < 3 at the first day of hospitalization
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 <55 bpm
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39877.044.12 |
| Other | nummer volgt |