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

COPD Clinical Trial

— STIT-2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01693146
• Other study ID #: UN4484
• Secondary ID: UN4484
• Status: Recruiting
• Phase: Phase 1
• First received: September 14, 2012
• Last updated: September 25, 2012
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: September 2012
• Source: Medical University Innsbruck
• Contact: Christian M Kaehler, MD
• Phone: 004351250423255
• Email: c.m.kaehler[@]i-med.ac.at
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• COPD
• Hypercapnia

Intervention

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
• Nasal insufflation of oxygen
Nasal insufflation of oxygen starting at at flow of 0.5 L/min.

Locations

Country	Name	City	State
Austria	Christian Kähler	Innsbruck
Germany	Pneumologie, Medizinische Klinik und Poliklinik I, University of Dresden	Dresden
Germany	Klinik für Innere Medizin V, Universitätsklinikum Homburg, University of Homburg/Saar	Homburg
Switzerland	Klinik und Poliklinik für Pneumologie, Inselspital Berne, University of Berne	Berne

Sponsors (2)

Lead Sponsor	Collaborator
Medical University Innsbruck	TNI Medical AG

Countries where clinical trial is conducted

Austria,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PaO2	Change in the partial oxygen pressure in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)	60 min	No
Secondary	O2%	Change in the oxygen saturation in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)	60 min	No
Secondary	PaCO2	Change in the PaCO2 in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)	60 min	No
Secondary	AaDO2	Change in the AaDO2 in the peripheral blood at a defined oxygen flow rate (L/min)	60 min	No
Secondary	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	No