A Phase 1 interventional study of Nasal oxygen insufflation with a TNI 20 oxy device and Standard Nasal Insufflation of oxygen in Oxygen Inhalation Therapy, sponsored by Medical University Innsbruck. Status unknown at 3 sites in 3 countries. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-09-19.
Sponsored by Medical University Innsbruck · Phase 1, Interventional, and Treatment
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.
1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.
This study's planned enrollment of 50 is above the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.
Browse Respiratory Aspiration studies →Medical University Innsbruck is the lead sponsor of 182 studies on the registry; 49 are open to participants now.
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Exclusion Criteria:
Standard Nasal Insufflation of oxygen
Device: Standard Nasal Insufflation of oxygen
Nasal oxygen insufflation with a TNI 20 oxy device
Device: Nasal oxygen insufflation with a TNI 20 oxy device
Nasal oxygen insufflation with a TNI 20 oxy device
Also known as: TNI 20 oxy
Standard Nasal Insufflation of oxygen
PaO2
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
This study is status unknown, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Medical University Innsbruck