Evaluation of Safety and Efficacy of Shorttime TNI Treatment in Patients with COPD Acute testing of oxygen demand using TNI vs. standard oxygen application in stable COPD patients An investigator-initiated, prospective, controlled, multicenter study
TNI, the nasal insufflation of a high flow of warm, humidified air, is an extremely comfortable and uncomplicated alternative to numerous other approaches in non-invasive ventilation (NIV). Up to now, NIV therapy could only be applied by masks with the associated complications as patients could not tolerate high airflow delivered by a thin nasal cannula without humidification and warming, thus causing concomitant negative effects. The new therapy TNI shows a high rate of acceptance by children, too. At present, there are two different types of devices available for nasal insufflation in clinics: TNI 20s, an air humidifier for clinical compressed air, and the TNI20 oxy, an air humidifier for clinical compressed air, which can be combined with oxygen. TNI 20 oxy The system, which is unique throughout the world, is optimized for the application of flows of up to 20L/min and fulfils the minimum requirements of the "American Society of Testing and Materials" for a high flow air humidifier in the non-invasive application of 10 mg H2O/L (equivalent to about 60% rel. humidity at an ambient temperature of 22°C) for the air humidity. The warming of the air flow by 5-15°C can be adjusted relative to the ambient temperature. Condensation is prevented in the nasal applicator by heating the tube as far as the nostrils. The device automatically controls humidity and temperature depending on the prevailing ambient conditions. The TNI®20s can be attached to the hospital infrastructure by means of a standard pressure regulator.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Nasal oxygen insufflation with a TNI 20 oxy device
Standard Nasal Insufflation of oxygen
Pneumology/USPH Innsbruck, Medical University Innsbruck
Innsbruck, Austria
RECRUITINGPneumologie, Medizinische Klinik und Poliklinik I, University Dresden
Dresden, Germany
RECRUITINGKlinik und Poliklinik für Pneumologie, Inselspital, Universitätsspital Bern
Bern, Switzerland
RECRUITINGPaO2
Change in the partial oxygen pressure in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
Time frame: Measures at Baseline and after 60 min
O2 %
Change in the oxygen saturation in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
Time frame: Measures at Baseline and after 60 min
PaCO2
Change in the partial carbon dioxide pressure in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
Time frame: Measures at Baseline and after 60 min
AaDO2
Change in the AaDO2 in the peripheral blood at a defined oxygen flow rate (L/min)
Time frame: Measures at Baseline and after 60 min
RV and TLC
Safety of the device in COPD °III or IV patients: No increase in the residual volume (RV) and the total lung capacity (TLC) \> 15% of the mean actual value at visits 1 and 2 (measurement 60 + 10 minutes after oxygen insufflation with a TNI system).
Time frame: Measures at Baseline and after 60 min
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