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

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:
Collaborator:
TNI Medical AG
Information provided by (Responsible Party):
Univ.-Prof. Dr. Christian M. Kaehler, Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT01693146
First received: September 14, 2012
Last updated: September 25, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
COPD
Hypercapnia
Device: Nasal oxygen insufflation with a TNI® 20 oxy device
Device: 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: Supportive Care
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Medical University Innsbruck:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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 PaCO2 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 ]
    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: 30
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Nasal insufflation of oxygen
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
Other Name: 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.

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01693146

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

Locations
Austria
Christian Kähler 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 of Dresden Not yet recruiting
Dresden, Germany, D-01307
Contact: Michael Halank, MD    0049 351 458 - 4721      
Principal Investigator: Gert Höffken, MD         
Klinik für Innere Medizin V, Universitätsklinikum Homburg, University of Homburg/Saar Recruiting
Homburg, Germany, D-66424
Contact: Heinrike Wilkens, MD    0049 6841 16-23633      
Switzerland
Klinik und Poliklinik für Pneumologie, Inselspital Berne, University of Berne Recruiting
Berne, Switzerland, CH-3010
Contact: Thomas Geiser, MD    0031 632 34 90      
Sponsors and Collaborators
Medical University Innsbruck
TNI Medical AG
Investigators
Principal Investigator: Christian M Kaehler, MD Medical University Innsbruck
  More Information

No publications provided

Responsible Party: Univ.-Prof. Dr. Christian M. Kaehler, a.Univ.-Prod. Dr., Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT01693146     History of Changes
Other Study ID Numbers: UN4484, UN4484
Study First Received: September 14, 2012
Last Updated: September 25, 2012
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University Innsbruck:
Oxygen
High Flow
COPD
Hypercapnia

Additional relevant MeSH terms:
Hypercapnia
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014