STIT-2: Evaluation of Safety and Efficacy of Short-time TNI® Treatment in Patients With COPD and Hypercapnia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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 Insufflation in COPD Patients With Hypercapnia at Rest

Conditions
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COPD, Hypercapnia

Intervention / Treatment
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* Device: Nasal oxygen insufflation with a TNI® 20 oxy device
* Device: Nasal insufflation of oxygen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nasal insufflation of oxygen<br>Nasal insufflation of oxygen starting at at flow of 0.5 L/min. | Device: Nasal insufflation of oxygen<br>* Nasal insufflation of oxygen starting at at flow of 0.5 L/min.<br>|
| Active Comparator: Nasal oxygen insufflation with a TNI® 20 oxy device<br>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<br>* Nasal insufflation at a constant high flow of 15 L/min with oxygen addition starting at 0.5 L/min<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxygen, High Flow, COPD, Hypercapnia