STIT-2: Evaluation of Safety and Efficacy of Short-time TNI® Treatment in Patients With COPD and Hypercapnia (STIT-2)
Primary Purpose
COPD, Hypercapnia
Status
Unknown status
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Nasal oxygen insufflation with a TNI® 20 oxy device
Nasal insufflation of oxygen
Sponsored by
About this trial
This is an interventional supportive care trial for COPD focused on measuring Oxygen, High Flow, COPD, Hypercapnia
Eligibility 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
Sites / Locations
- Christian KählerRecruiting
- Pneumologie, Medizinische Klinik und Poliklinik I, University of Dresden
- Klinik für Innere Medizin V, Universitätsklinikum Homburg, University of Homburg/SaarRecruiting
- Klinik und Poliklinik für Pneumologie, Inselspital Berne, University of BerneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Nasal insufflation of oxygen
Nasal oxygen insufflation with a TNI® 20 oxy device
Arm Description
Nasal insufflation of oxygen starting at at flow of 0.5 L/min.
Device: TNI®20 oxy Nasal insufflation at a constant high flow of 15 L/min with oxygen addition starting at 0.5 L/min
Outcomes
Primary Outcome Measures
PaO2
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%
Change in the oxygen saturation in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
PaCO2
Change in the PaCO2 in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
AaDO2
Change in the AaDO2 in the peripheral blood at a defined oxygen flow rate (L/min)
RV and TLC
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).
Full Information
NCT ID
NCT01693146
First Posted
September 14, 2012
Last Updated
September 25, 2012
Sponsor
Medical University Innsbruck
Collaborators
TNI Medical AG
1. Study Identification
Unique Protocol Identification Number
NCT01693146
Brief Title
STIT-2: Evaluation of Safety and Efficacy of Short-time TNI® Treatment in Patients With COPD and Hypercapnia
Acronym
STIT-2
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University Innsbruck
Collaborators
TNI Medical AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Hypercapnia
Keywords
Oxygen, High Flow, COPD, Hypercapnia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nasal insufflation of oxygen
Arm Type
Active Comparator
Arm Description
Nasal insufflation of oxygen starting at at flow of 0.5 L/min.
Arm Title
Nasal oxygen insufflation with a TNI® 20 oxy device
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Nasal oxygen insufflation with a TNI® 20 oxy device
Intervention Description
Nasal insufflation at a constant high flow of 15 L/min with oxygen addition starting at 0.5 L/min
Intervention Type
Device
Intervention Name(s)
Nasal insufflation of oxygen
Intervention Description
Nasal insufflation of oxygen starting at at flow of 0.5 L/min.
Primary Outcome Measure Information:
Title
PaO2
Description
Change in the partial oxygen pressure in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
Time Frame
60 min
Secondary Outcome Measure Information:
Title
O2%
Description
Change in the oxygen saturation in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
Time Frame
60 min
Title
PaCO2
Description
Change in the PaCO2 in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
Time Frame
60 min
Title
AaDO2
Description
Change in the AaDO2 in the peripheral blood at a defined oxygen flow rate (L/min)
Time Frame
60 min
Title
RV and TLC
Description
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).
Time Frame
60 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian M Kaehler, MD
Phone
004351250423255
Email
c.m.kaehler@i-med.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian M Kaehler, MD
Organizational Affiliation
Medical University Innsbruck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christian Kähler
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian M Kaehler, MD
Phone
004351250423255
Email
c.m.kaehler@i-med.ac.at
Facility Name
Pneumologie, Medizinische Klinik und Poliklinik I, University of Dresden
City
Dresden
ZIP/Postal Code
D-01307
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Halank, MD
Phone
0049 351 458 - 4721
First Name & Middle Initial & Last Name & Degree
Gert Höffken, MD
Facility Name
Klinik für Innere Medizin V, Universitätsklinikum Homburg, University of Homburg/Saar
City
Homburg
ZIP/Postal Code
D-66424
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heinrike Wilkens, MD
Phone
0049 6841 16-23633
Facility Name
Klinik und Poliklinik für Pneumologie, Inselspital Berne, University of Berne
City
Berne
ZIP/Postal Code
CH-3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Geiser, MD
Phone
0031 632 34 90
12. IPD Sharing Statement
Citations:
PubMed Identifier
29149867
Citation
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.
Results Reference
derived
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STIT-2: Evaluation of Safety and Efficacy of Short-time TNI® Treatment in Patients With COPD and Hypercapnia
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