Evaluation of Safety and Efficacy of Shorttime TNI Treatment in Patients With COPD

Oxygen Inhalation Therapy Clinical Trial

— STIT-1  

Official title:

STIT-1 Evaluation of Safety and Efficacy of Shorttime TNI Treatment in Patients With COPD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01686893
• Other study ID #: AN3547
• Secondary ID: AN 3546
• Status: Recruiting
• Phase: Phase 1
• First received: September 13, 2012
• Last updated: September 18, 2012
• Start date: February 2009
• Est. completion date: March 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 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Oxygen Inhalation Therapy

Intervention

Device:
• Nasal oxygen insufflation with a TNI 20 oxy device
Nasal oxygen insufflation with a TNI 20 oxy device
• Standard Nasal Insufflation of oxygen
Standard Nasal Insufflation of oxygen

Locations

Country	Name	City	State
Austria	Pneumology/USPH Innsbruck, Medical University Innsbruck	Innsbruck
Germany	Pneumologie, Medizinische Klinik und Poliklinik I, University Dresden	Dresden
Switzerland	Klinik und Poliklinik für Pneumologie, Inselspital, Universitätsspital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

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)	Measures at Baseline and after 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)	Measures at Baseline and after 60 min	No
Secondary	PaCO2	Change in the partial carbon dioxide pressure in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)	Measures at Baseline and after 60 min	No
Secondary	AaDO2	Change in the AaDO2 in the peripheral blood at a defined oxygen flow rate (L/min)	Measures at Baseline and after 60 min	No
Secondary	RV and TLC	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).	Measures at Baseline and after 60 min	No