STIT-2: Evaluation of Safety and Efficacy of Short-time TNI® Treatment in Patients With COPD and Hypercapnia
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
COPD Hypercapnia |
Device: Nasal oxygen insufflation with a TNI® 20 oxy device Device: 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: Supportive Care |
| Official Title: | 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 Insufflation in COPD Patients With Hypercapnia at Rest |
- PaO2 [ Time Frame: 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: 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: 60 min ] [ Designated as safety issue: No ]Change in the PaCO2 in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
- AaDO2 [ Time Frame: 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: 60 min ] [ Designated as safety issue: No ]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: | 30 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Nasal insufflation of oxygen
Nasal insufflation of oxygen starting at at flow of 0.5 L/min.
|
Device: Nasal insufflation of oxygen
Nasal insufflation of oxygen starting at at flow of 0.5 L/min.
Other Name: Nasal insufflation of oxygen
|
|
Active Comparator: Nasal oxygen insufflation with a TNI® 20 oxy device
Device: TNI®20 oxy Nasal insufflation at a constant high flow of 15 L/min with oxygen addition starting at 0.5 L/min
|
Device: Nasal oxygen insufflation with a TNI® 20 oxy device
Nasal insufflation at a constant high flow of 15 L/min with oxygen addition starting at 0.5 L/min
Other Name: Nasal oxygen insufflation with a TNI® 20 oxy device
|
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.
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.
Eligibility| Ages Eligible for Study: | 30 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- COPD patients with an indication for long-term oxygen therapy (LTOT)
- Presence of hypercapnia at rest without oxygen supplementation (PaCO2 > 45 mmHg)
- Age 30 - 85 years
- Functional GOLD class: COPD GOLD IV as defined by the following:
FEV1/FVC < 70% and a Post-bronchodilator FEV1 < 30% or FEV1 < 50% and a PaO2 < 60 mmHg and/or PaCO2 > 50 mmHg
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
- Severe anaemia, defined by a haemoglobin <8.5 G/L
- 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 | |
| Christian Kähler | 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 of Dresden | Not yet recruiting |
| Dresden, Germany, D-01307 | |
| Contact: Michael Halank, MD 0049 351 458 - 4721 | |
| Principal Investigator: Gert Höffken, MD | |
| Klinik für Innere Medizin V, Universitätsklinikum Homburg, University of Homburg/Saar | Recruiting |
| Homburg, Germany, D-66424 | |
| Contact: Heinrike Wilkens, MD 0049 6841 16-23633 | |
| Switzerland | |
| Klinik und Poliklinik für Pneumologie, Inselspital Berne, University of Berne | Recruiting |
| Berne, Switzerland, CH-3010 | |
| Contact: Thomas Geiser, MD 0031 632 34 90 | |
| Principal Investigator: | Christian M Kaehler, MD | Medical University Innsbruck |
More Information
No publications provided
| Responsible Party: | Univ.-Prof. Dr. Christian M. Kaehler, a.Univ.-Prod. Dr., Medical University Innsbruck |
| ClinicalTrials.gov Identifier: | NCT01693146 History of Changes |
| Other Study ID Numbers: | UN4484, UN4484 |
| Study First Received: | September 14, 2012 |
| Last Updated: | September 25, 2012 |
| Health Authority: | Austria: Ethikkommission |
Keywords provided by Medical University Innsbruck:
|
Oxygen High Flow COPD Hypercapnia |
Additional relevant MeSH terms:
|
Hypercapnia Pulmonary Disease, Chronic Obstructive Signs and Symptoms, Respiratory Signs and Symptoms |
Lung Diseases, Obstructive Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 18, 2013