Clinical trial NCT01686893: Evaluation of Safety and Efficacy of Shorttime TNI Treatment in Patients With COPD
Official title: STIT-1 Evaluation of Safety and Efficacy of Shorttime TNI Treatment in Patients With COPD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Oxygen Inhalation Therapy
Keywords: Oxygen, Insufflation, COPD, High Flow Treatment
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2012-09-18
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: PaO2
timeFrame: Measures at Baseline and after 60 min
Secondary outcomes:
measure: O2 %
timeFrame: Measures at Baseline and after 60 min
measure: PaCO2
timeFrame: Measures at Baseline and after 60 min
measure: AaDO2
timeFrame: Measures at Baseline and after 60 min
measure: RV and TLC
timeFrame: Measures at Baseline and after 60 min
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Pneumology/USPH Innsbruck, Medical University Innsbruck
city: Dresden
country: Germany
facility: Pneumologie, Medizinische Klinik und Poliklinik I, University Dresden
city: Bern
country: Switzerland
facility: Klinik und Poliklinik für Pneumologie, Inselspital, Universitätsspital Bern
Study officials:
affiliation: Pneumology, Medical University Innsbruck
name: Christian M Kaehler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vogelsinger H, Halank M, Braun S, Wilkens H, Geiser T, Ott S, Stucki A, Kaehler CM. Efficacy and safety of nasal high-flow oxygen in COPD patients. BMC Pulm Med. 2017 Nov 17;17(1):143. doi: 10.1186/s12890-017-0486-3.