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

Phase 1

• Conditions: COPD; Hypercapnia
• Interventions: Device: Nasal insufflation of oxygen; Device: Nasal oxygen insufflation with a TNI® 20 oxy device

• Registration Number: NCT01693146
• Lead Sponsor: Medical University Innsbruck

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.

Study Timeline

• Study Start: 2011-12
• Status Verified: 2012-09
• Study First Submitted: 2012-09-14
• Study First Submitted QC: 2012-09-25
• Last Update Submitted: 2012-09-25
• Study First Posted: 2012-09-26
• Last Update Posted: 2012-09-26
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nasal insufflation of oxygen	Nasal insufflation of oxygen	Nasal insufflation of oxygen starting at at flow of 0.5 L/min.
Nasal oxygen insufflation with a TNI® 20 oxy device	Nasal oxygen insufflation with a TNI® 20 oxy device	Device: TNI®20 oxy Nasal insufflation at a constant high flow of 15 L/min with oxygen addition starting at 0.5 L/min

Primary Outcome Measures

Name	Time	Method
PaO2	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%	60 min	Change in the oxygen saturation in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
PaCO2	60 min	Change in the PaCO2 in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
AaDO2	60 min	Change in the AaDO2 in the peripheral blood at a defined oxygen flow rate (L/min)
RV and TLC	60 min	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 (4)

Klinik und Poliklinik für Pneumologie, Inselspital Berne, University of Berne; 🇨🇭 Berne, Switzerland

Christian Kähler; 🇦🇹 Innsbruck, Austria

Klinik für Innere Medizin V, Universitätsklinikum Homburg, University of Homburg/Saar; 🇩🇪 Homburg, Germany

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