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

Phase 1

• Conditions: Oxygen Inhalation Therapy
• Interventions: Device: Standard Nasal Insufflation of oxygen; Device: Nasal oxygen insufflation with a TNI 20 oxy device

• Registration Number: NCT01686893
• Lead Sponsor: Medical University Innsbruck

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.

Study Timeline

• Study Start: 2009-02
• Status Verified: 2012-09
• Study First Submitted: 2012-09-13
• Study First Submitted QC: 2012-09-13
• Study First Posted: 2012-09-18
• Last Update Submitted: 2012-09-18
• Last Update Posted: 2012-09-19
• Primary Completion: 2013-02
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard Nasal Insufflation of oxygen	Standard Nasal Insufflation of oxygen	Standard Nasal Insufflation of oxygen
Nasal oxygen insufflation with a TNI 20 oxy device	Nasal oxygen insufflation with a TNI 20 oxy device	Nasal oxygen insufflation with a TNI 20 oxy device

Primary Outcome Measures

Name	Time	Method
PaO2	Measures at Baseline and after 60 min	Change in the partial oxygen pressure in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)

Secondary Outcome Measures

Name	Time	Method
O2 %	Measures at Baseline and after 60 min	Change in the oxygen saturation in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
PaCO2	Measures at Baseline and after 60 min	Change in the partial carbon dioxide pressure in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
AaDO2	Measures at Baseline and after 60 min	Change in the AaDO2 in the peripheral blood at a defined oxygen flow rate (L/min)
RV and TLC	Measures at Baseline and after 60 min	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).

Trial Locations

Locations (3)

Pneumologie, Medizinische Klinik und Poliklinik I, University Dresden; 🇩🇪 Dresden, Germany

Pneumology/USPH Innsbruck, Medical University Innsbruck; 🇦🇹 Innsbruck, Austria

Klinik und Poliklinik für Pneumologie, Inselspital, Universitätsspital Bern; 🇨🇭 Bern, Switzerland