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

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ClinicalTrials.gov Identifier: NCT01693146
Recruitment Status : Unknown
Verified September 2012 by Univ.-Prof. Dr. Christian M. Kaehler, Medical University Innsbruck.
Recruitment status was:  Recruiting
First Posted : September 26, 2012
Last Update Posted : September 26, 2012
Sponsor:
Collaborator:
TNI Medical AG
Information provided by (Responsible Party):
Univ.-Prof. Dr. Christian M. Kaehler, Medical University Innsbruck

Tracking Information
First Submitted Date  ICMJE September 14, 2012
First Posted Date  ICMJE September 26, 2012
Last Update Posted Date September 26, 2012
Study Start Date  ICMJE December 2011
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2012)
PaO2 [ Time Frame: 60 min ]
Change in the partial oxygen pressure in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2012)
  • O2% [ Time Frame: 60 min ]
    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 ]
    Change in the PaCO2 in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
  • AaDO2 [ Time Frame: 60 min ]
    Change in the AaDO2 in the peripheral blood at a defined oxygen flow rate (L/min)
  • RV and TLC [ Time Frame: 60 min ]
    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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE STIT-2: Evaluation of Safety and Efficacy of Short-time TNI® Treatment in Patients With COPD and Hypercapnia
Official Title  ICMJE 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
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • COPD
  • Hypercapnia
Intervention  ICMJE
  • 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
  • Device: Nasal insufflation of oxygen
    Nasal insufflation of oxygen starting at at flow of 0.5 L/min.
Study Arms  ICMJE
  • Active Comparator: Nasal insufflation of oxygen
    Nasal insufflation of oxygen starting at at flow of 0.5 L/min.
    Intervention: Device: 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
    Intervention: Device: Nasal oxygen insufflation with a TNI® 20 oxy device
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 25, 2012)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Germany,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01693146
Other Study ID Numbers  ICMJE UN4484
UN4484 ( Other Identifier: Ethic Committee Innsbruck )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Univ.-Prof. Dr. Christian M. Kaehler, Medical University Innsbruck
Study Sponsor  ICMJE Medical University Innsbruck
Collaborators  ICMJE TNI Medical AG
Investigators  ICMJE
Principal Investigator: Christian M Kaehler, MD Medical University Innsbruck
PRS Account Medical University Innsbruck
Verification Date September 2012

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