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| ID | Type | Description | Link |
|---|---|---|---|
| UN4484 | Other Identifier | Ethic Committee Innsbruck |
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| Name | Class |
|---|---|
| TNI Medical AG | INDUSTRY |
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Evaluation of Safety and Efficacy of Short time TNI Treatment in Patients with COPD and hypercapnia.
Acute testing of oxygen demand using TNI vs. standard oxygen application in stable COPD patients with hypercapnia.
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.
In another ongoing study (STIT-1) TNI 20 oxy was evaluated for its safety in COPD patients without hypercapnia. In a first interim analysis which included 14 patients high flow oxygen delivery was safe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal insufflation of oxygen | Active Comparator | Nasal insufflation of oxygen starting at at flow of 0.5 L/min. |
|
| Nasal oxygen insufflation with a TNI® 20 oxy device | Active Comparator | Device: TNI®20 oxy Nasal insufflation at a constant high flow of 15 L/min with oxygen addition starting at 0.5 L/min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal oxygen insufflation with a TNI® 20 oxy device | Device | Nasal insufflation at a constant high flow of 15 L/min with oxygen addition starting at 0.5 L/min |
|
| Measure | Description | Time Frame |
|---|---|---|
| PaO2 | Change in the partial oxygen pressure in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min) | 60 min |
| Measure | Description | Time Frame |
|---|---|---|
| O2% | Change in the oxygen saturation in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min) | 60 min |
| PaCO2 | Change in the PaCO2 in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min) |
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Inclusion Criteria:
FEV1/FVC < 70% and a Post-bronchodilator FEV1 < 30% or FEV1 < 50% and a PaO2 < 60 mmHg and/or PaCO2 > 50 mmHg
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian M Kaehler, MD | Contact | 004351250423255 | c.m.kaehler@i-med.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Christian M Kaehler, MD | Medical University Innsbruck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christian Kähler | Recruiting | Innsbruck | A-6020 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29149867 | Derived | Vogelsinger H, Halank M, Braun S, Wilkens H, Geiser T, Ott S, Stucki A, Kaehler CM. Efficacy and safety of nasal high-flow oxygen in COPD patients. BMC Pulm Med. 2017 Nov 17;17(1):143. doi: 10.1186/s12890-017-0486-3. |
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| Nasal insufflation of oxygen | Device | Nasal insufflation of oxygen starting at at flow of 0.5 L/min. |
|
| 60 min |
| AaDO2 | Change in the AaDO2 in the peripheral blood at a defined oxygen flow rate (L/min) | 60 min |
| RV and TLC | 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). | 60 min |
| Pneumologie, Medizinische Klinik und Poliklinik I, University of Dresden | Not yet recruiting | Dresden | D-01307 | Germany |
|
| Klinik für Innere Medizin V, Universitätsklinikum Homburg, University of Homburg/Saar | Recruiting | Homburg | D-66424 | Germany |
|
| Klinik und Poliklinik für Pneumologie, Inselspital Berne, University of Berne | Recruiting | Bern | CH-3010 | Switzerland |
|
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D006935 | Hypercapnia |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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