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

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

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.

Study Overview

• Status: Unknown
• Conditions: COPD; Hypercapnia
• Intervention / Treatment: Device: Nasal insufflation of oxygen; Device: Nasal oxygen insufflation with a TNI® 20 oxy device

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Christian M Kaehler, MD; Phone Number: 004351250423255; Email: c.m.kaehler@i-med.ac.at

Study Locations

• Austria
  • Innsbruck, Austria, A-6020
    • Recruiting
    • Christian Kähler
    • Contact: Christian M Kaehler, MD; Phone Number: 004351250423255; Email: c.m.kaehler@i-med.ac.at
• Germany
  • Dresden, Germany, D-01307
    • Not yet recruiting
    • Pneumologie, Medizinische Klinik und Poliklinik I, University of Dresden
    • Contact: Michael Halank, MD; Phone Number: 0049 351 458 - 4721
    • Principal Investigator: Gert Höffken, MD
  • Homburg, Germany, D-66424
    • Recruiting
    • Klinik für Innere Medizin V, Universitätsklinikum Homburg, University of Homburg/Saar
    • Contact: Heinrike Wilkens, MD; Phone Number: 0049 6841 16-23633
• Switzerland
  • Berne, Switzerland, CH-3010
    • Recruiting
    • Klinik und Poliklinik für Pneumologie, Inselspital Berne, University of Berne
    • Contact: Thomas Geiser, MD; Phone Number: 0031 632 34 90

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nasal insufflation of oxygen; Nasal insufflation of oxygen starting at at flow of 0.5 L/min.	Device: Nasal insufflation of oxygen; Nasal insufflation of oxygen starting at at flow of 0.5 L/min.
Active Comparator: 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	Device: Nasal oxygen insufflation with a TNI® 20 oxy device; Nasal insufflation at a constant high flow of 15 L/min with oxygen addition starting at 0.5 L/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PaO2	Change in the partial oxygen pressure in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)	60 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
O2%	Change in the oxygen saturation in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)	60 min
PaCO2	Change in the PaCO2 in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)	60 min
AaDO2	Change in the AaDO2 in the peripheral blood at a defined oxygen flow rate (L/min)	60 min
RV and TLC	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).	60 min

Collaborators and Investigators

• Sponsor: Medical University Innsbruck
• Collaborators: TNI Medical AG
• Investigators: Principal Investigator: Christian M Kaehler, MD, Medical University Innsbruck

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: September 14, 2012
• First Submitted That Met QC Criteria: September 25, 2012
• First Posted (Estimate): September 26, 2012

Study Record Updates

• Last Update Posted (Estimate): September 26, 2012
• Last Update Submitted That Met QC Criteria: September 25, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: COPD; Hypercapnia; Oxygen; High Flow
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypercapnia
• Other Study ID Numbers: UN4484 (Other Identifier: Ethic Committee Innsbruck)