Clinical trial NCT01693146: STIT-2: Evaluation of Safety and Efficacy of Short-time TNI® Treatment in Patients With COPD and Hypercapnia
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: COPD
Hypercapnia
Keywords: Oxygen
High Flow
COPD
Hypercapnia
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
Collaborators: name: TNI Medical AG
First posted: 2012-09-26
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: PaO2
timeFrame: 60 min
Secondary outcomes:
measure: O2%
timeFrame: 60 min
measure: PaCO2
timeFrame: 60 min
measure: AaDO2
timeFrame: 60 min
measure: RV and TLC
timeFrame: 60 min
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Christian Kähler
city: Dresden
country: Germany
facility: Pneumologie, Medizinische Klinik und Poliklinik I, University of Dresden
city: Homburg
country: Germany
facility: Klinik für Innere Medizin V, Universitätsklinikum Homburg, University of Homburg/Saar
city: Berne
country: Switzerland
facility: Klinik und Poliklinik für Pneumologie, Inselspital Berne, University of Berne
Study officials:
affiliation: 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.