Evaluation of Safety and Efficacy of Shorttime TNI Treatment in Patients With COPD (STIT-1)

STIT-1 Evaluation of Safety and Efficacy of Shorttime TNI Treatment in Patients With COPD

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

Study Overview

• Status: Unknown
• Conditions: Oxygen Inhalation Therapy
• Intervention / Treatment: Device: Standard 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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, A-6020
    • Recruiting
    • Pneumology/USPH Innsbruck, Medical University Innsbruck
    • Contact: Christian M Kaehler, MD; Phone Number: 004351250423255; Email: c.m.kaehler@i-med.ac.at
• Germany
  • Dresden, Germany, D-01307
    • Recruiting
    • Pneumologie, Medizinische Klinik und Poliklinik I, University Dresden
    • Contact: Michael Halank, MD; Phone Number: 0049 351 458 4721
    • Sub-Investigator: Gert Höffken, MD
• Switzerland
  • Bern, Switzerland, CH-3010
    • Recruiting
    • Klinik und Poliklinik für Pneumologie, Inselspital, Universitätsspital Bern
    • Contact: Thomas Geiser, MD; Phone Number: 0031 632 34 90

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: Standard Nasal Insufflation of oxygen	Device: Standard Nasal Insufflation of oxygen; Standard Nasal Insufflation of oxygen
Active Comparator: Nasal oxygen insufflation with a TNI 20 oxy device	Device: Nasal oxygen insufflation with a TNI 20 oxy device; Nasal oxygen insufflation with a TNI 20 oxy device; Other Names: TNI 20 oxy

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

Collaborators and Investigators

• Sponsor: Medical University Innsbruck
• Investigators: Principal Investigator: Christian M Kaehler, MD, Pneumology, 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: February 1, 2009
• Primary Completion (Anticipated): February 1, 2013
• Study Completion (Anticipated): March 1, 2013

Study Registration Dates

• First Submitted: September 13, 2012
• First Submitted That Met QC Criteria: September 13, 2012
• First Posted (Estimate): September 18, 2012

Study Record Updates

• Last Update Posted (Estimate): September 19, 2012
• Last Update Submitted That Met QC Criteria: September 18, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Oxygen, Insufflation, COPD, High Flow Treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: AN3547; AN 3546 (Other Identifier: Ethics Committee Innsbruck)