Effectiveness of TNI vs. BiPAP in Chronic Global Insufficiency in COPD Patients

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.

Inclusion criteria

• 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

Exclusion criteria

• 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
• clinical instability or acute illness (e.g. acute myocardial infarction, tachycardial atrial fibrillation)
• signs of cardial decompensation (e.g. edema in the lower limbs, pleural effusion)
• other serious concomitant diseases, the assessment of eligibility is at the discretion of the investigator
• contraindications for NIV
• anamnestic suspicion or proven obstructive sleep apnea (OSA)
• relevant systemic infections, assessment of eligibility is at the discretion of the investigator
• BMI > 30
• other additional pulmonary diseases of other genesis or diseases that affect breathing (e.g. mucoviscidosis, scoliosis, muscular diseases)
• lack of compliance
• participation in other interventional trials at the same time
• pregnant or nursing women
• fertile female patients without effective contraceptive measures during trial participation