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

Medical University Innsbruck

Status and phase: Unknown; Phase 1

Conditions: Hypercapnia; COPD

Treatments: Device: Nasal oxygen insufflation with a TNI® 20 oxy device; Device: Nasal insufflation of oxygen

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01693146

UN4484 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Nasal insufflation of oxygen

Active Comparator group

Description:

Nasal insufflation of oxygen starting at at flow of 0.5 L/min.

Treatment:

Device: Nasal insufflation of oxygen

Nasal oxygen insufflation with a TNI® 20 oxy device

Active Comparator group

Description:

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

Treatment:

Device: Nasal oxygen insufflation with a TNI® 20 oxy device