Evaluation of the effect of the AlphaCoreTM on breathlessness and time to discharge in hospitalised subjects with COPD

Authors
Category Primary study
Registry of TrialsNetherlands Trial Register
Year 2012
INTERVENTION: Intervention subjects will receive non‐invasive vagal nerve stimulation three times a day, according to the device instructions, starting on the first day following admission, until the day of discharge. The control subjects will receive identical care, but with sham stimulation, three times a day. CONDITION: ; COPD, Exacerbation ; ; 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: 1. Breathlessness, measured through the BORG scale from 0 (no breathlessness) until 10 (extreme breathlessness), before and after (sham)stimulation; ; ; 2. Change in breathlessness (Borg score), measured in hours; ; ; 3. Airway resistance, measured with Forced Oscillation Technique (FOT); ; ; 4. Description of position of the vagal nerve, on the left and right side of the neck, through a one‐time ultrasound examination; ; ; 5. Adverse Events. INCLUSION CRITERIA: 1. Age > 40 years, male or female; 2. Ability to understand and read Dutch; 3. Diagnosis of COPD stage II, III or IV according to GOLD; 4. Hospitalised at ward A4 or C4; 5. Is able to give written informed consent; 6. Borg score <3 at the first day of hospitalization.
Epistemonikos ID: b46cdfc75870abaffc9252df22f0f5c3050433e7
First added on: Aug 25, 2024