Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Leipzig
With
TNI Medical AG
The trial consists of 12 weeks of therapy that is divided into two sections. In the first 6-week section patients receive treatment with either TNI or BiPAP and in the second 6-week section treatment is changed. The starting therapy is allocated to the patients via randomisation and should be started directly after the baseline visit.
The treatment and the follow-up period end with the second visit after the second treatment section and the patient decides which device he/she wants to use further.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
presence of COPD with chronic respiratory global insufficiency
chronic day-hypercapnia with pCO2 \>= 50 mmHg and typical symptoms of ventilatory insufficiency OR patients with exacerbation (after abate of acute symptomatology) with documented hypercapnia \>= 50 mmHG on preliminary findings
age 18 or older
the patient or caretaker must be able to operate the device after a specific training
patient must be willing to use the nHF-/BiPAP-device for the whole trial period for at least 5 hours/day
patient must be able to answer the questionnaires
written informed consent is obtained
You may not be if
presence of acute respiratory insufficiency
exacerbation of type I or II in the last 4 weeks
conservative therapy including long-term oxygen therapy according to GOLD update 2011 is not exhausted
previous treatment with NIV (non-invasive ventilation) in the last 14 days
