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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Medical University Innsbruck.
Recruitment status was  Recruiting
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

September 13, 2012
September 18, 2012
February 2009
February 2013   (final data collection date for primary outcome measure)
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)
PaO2 [ Time Frame: 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)
Complete list of historical versions of study NCT01686893 on ClinicalTrials.gov Archive Site
  • 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).

  • O2 % [ Time Frame: 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: 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: 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: 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).

Not Provided
Not Provided
 
Evaluation of Safety and Efficacy of Shorttime TNI Treatment in Patients With COPD
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

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Oxygen Inhalation Therapy
  • Device: Nasal oxygen insufflation with a TNI 20 oxy device
    Nasal oxygen insufflation with a TNI 20 oxy device
    Other Name: TNI 20 oxy
  • Device: Standard Nasal Insufflation of oxygen
    Standard Nasal Insufflation of oxygen
    Other Name: Standard Nasal Insufflation of oxygen
  • Active Comparator: Standard Nasal Insufflation of oxygen
    Standard Nasal Insufflation of oxygen
    Intervention: Device: 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
    Intervention: Device: Nasal oxygen insufflation with a TNI 20 oxy device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
March 2013
February 2013   (final data collection date for primary outcome measure)

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

Both
30 Years to 80 Years
No
Contact: Christian M Kaehler, MD 004351250423255 c.m.kaehler@i-med.ac.at
Austria,   Germany,   Switzerland
 
NCT01686893
AN3547, AN 3546
No
Univ.-Prof. Dr. Christian M. Kaehler, Medical University Innsbruck
Medical University Innsbruck
Not Provided
Principal Investigator: Christian M Kaehler, MD Pneumology, Medical University Innsbruck
Medical University Innsbruck
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP