Evaluation of Safety and Efficacy of Shorttime TNI Treatment in Patients With COPD (STIT-1)
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Oxygen Inhalation Therapy |
Device: Nasal oxygen insufflation with a TNI 20 oxy device Device: Standard Nasal Insufflation of oxygen |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | STIT-1 Evaluation of Safety and Efficacy of Shorttime TNI Treatment in Patients With COPD |
- PaO2 [ Time Frame: Measures at Baseline and after 60 min ] [ Designated as safety issue: No ]Change in the partial oxygen pressure in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
- O2 % [ Time Frame: Measures at Baseline and after 60 min ] [ Designated as safety issue: No ]Change in the oxygen saturation in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
- PaCO2 [ Time Frame: Measures at Baseline and after 60 min ] [ Designated as safety issue: No ]Change in the partial carbon dioxide pressure in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
- AaDO2 [ Time Frame: Measures at Baseline and after 60 min ] [ Designated as safety issue: No ]Change in the AaDO2 in the peripheral blood at a defined oxygen flow rate (L/min)
- RV and TLC [ Time Frame: Measures at Baseline and after 60 min ] [ Designated as safety issue: No ]
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).
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Standard Nasal Insufflation of oxygen
Standard Nasal Insufflation of oxygen
|
Device: Standard Nasal Insufflation of oxygen
Standard Nasal Insufflation of oxygen
Other Name: Standard Nasal Insufflation of oxygen
|
|
Active Comparator: Nasal oxygen insufflation with a TNI 20 oxy device
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
Other Name: TNI 20 oxy
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- COPD patients with an indication for long-term oxygen therapy Age 30 - 80 years COPD GOLD °III
Exclusion Criteria:
- Clinical instability of the patient No lung function testing possible Exacerbation within the last 14 days prior to inclusion into the study Serious concomitant diseases that may jeopardize the inclusion of the patient into the study from the investigator's point of view Anaemia, defined by a haemoglobin <10 G/L Patients with hypercapnia, defined by a paCO <46mmHg Participation of the patient in any other ongoing study
Contacts and Locations| Contact: Christian M Kaehler, MD | 004351250423255 | c.m.kaehler@i-med.ac.at |
| Austria | |
| Pneumology/USPH Innsbruck, Medical University Innsbruck | Recruiting |
| Innsbruck, Austria, A-6020 | |
| Contact: Christian M Kaehler, MD 004351250423255 c.m.kaehler@i-med.ac.at | |
| Germany | |
| Pneumologie, Medizinische Klinik und Poliklinik I, University Dresden | Recruiting |
| Dresden, Germany, D-01307 | |
| Contact: Michael Halank, MD 0049 351 458 4721 | |
| Sub-Investigator: Gert Höffken, MD | |
| Switzerland | |
| Klinik und Poliklinik für Pneumologie, Inselspital, Universitätsspital Bern | Recruiting |
| Bern, Switzerland, CH-3010 | |
| Contact: Thomas Geiser, MD 0031 632 34 90 | |
| Principal Investigator: | Christian M Kaehler, MD | Pneumology, Medical University Innsbruck |
More Information
No publications provided
| Responsible Party: | Univ.-Prof. Dr. Christian M. Kaehler, Head of Pneumology, Clinical Professor, Medical University Innsbruck |
| ClinicalTrials.gov Identifier: | NCT01686893 History of Changes |
| Other Study ID Numbers: | AN3547, AN 3546 |
| Study First Received: | September 13, 2012 |
| Last Updated: | September 18, 2012 |
| Health Authority: | Austria: Ethikkommission |
Keywords provided by Medical University Innsbruck:
|
Oxygen, Insufflation, COPD, High Flow Treatment |
Additional relevant MeSH terms:
|
Respiratory Aspiration Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
ClinicalTrials.gov processed this record on June 13, 2013