STIT-2: Evaluation of Safety & Efficacy of Short-time TNI® Treatment in

Status Recruiting

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.

Clinical Trial 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. ;

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

Clinical Trial Details

NCT number	NCT01693146
Study type	Interventional
Source	Medical University Innsbruck
Contact	Christian M Kaehler, MD
Phone	004351250423255
Email	c.m.kaehler@i-med.ac.at
Status	Recruiting
Phase	Phase 1
Start date	December 2011
Completion date	December 2013

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms