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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Medical University Innsbruck
Sponsor:
Information provided by (Responsible Party):
Univ.-Prof. Dr. Christian M. Kaehler, Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT01686893
First received: September 13, 2012
Last updated: September 18, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention Phase
Oxygen Inhalation Therapy
Device: Nasal oxygen insufflation with a TNI 20 oxy device
Device: Standard Nasal Insufflation of oxygen
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: STIT-1 Evaluation of Safety and Efficacy of Shorttime TNI Treatment in Patients With COPD

Resource links provided by NLM:


Further study details as provided by Medical University Innsbruck:

Primary Outcome Measures:
  • PaO2 [ Time Frame: Measures at Baseline and after 60 min ] [ Designated as safety issue: No ]
    Change in the partial oxygen pressure in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)


Secondary Outcome Measures:
  • O2 % [ Time Frame: Measures at Baseline and after 60 min ] [ Designated as safety issue: No ]
    Change in the oxygen saturation in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)

  • PaCO2 [ Time Frame: Measures at Baseline and after 60 min ] [ Designated as safety issue: No ]
    Change in the partial carbon dioxide pressure in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)

  • AaDO2 [ Time Frame: Measures at Baseline and after 60 min ] [ Designated as safety issue: No ]
    Change in the AaDO2 in the peripheral blood at a defined oxygen flow rate (L/min)

  • RV and TLC [ Time Frame: Measures at Baseline and after 60 min ] [ Designated as safety issue: No ]

    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).



Estimated Enrollment: 50
Study Start Date: February 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Nasal Insufflation of oxygen
Standard Nasal Insufflation of oxygen
Device: Standard Nasal Insufflation of oxygen
Standard Nasal Insufflation of oxygen
Other Name: Standard Nasal Insufflation of oxygen
Active Comparator: Nasal oxygen insufflation with a TNI 20 oxy device
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 Name: TNI 20 oxy

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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01686893

Contacts
Contact: Christian M Kaehler, MD 004351250423255 c.m.kaehler@i-med.ac.at

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

No publications provided

Responsible Party: Univ.-Prof. Dr. Christian M. Kaehler, Head of Pneumology, Clinical Professor, Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT01686893     History of Changes
Other Study ID Numbers: AN3547, AN 3546
Study First Received: September 13, 2012
Last Updated: September 18, 2012
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University Innsbruck:
Oxygen, Insufflation, COPD, High Flow Treatment

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014