Evaluation of Safety and Efficacy of Shorttime TNI Treatment in Patients With COPD
STIT-1
STIT-1 Evaluation of Safety and Efficacy of Shorttime TNI Treatment in Patients With COPD
2 other identifiers
interventional
50
3 countries
3
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2009
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 13, 2012
CompletedFirst Posted
Study publicly available on registry
September 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedSeptember 19, 2012
September 1, 2012
4 years
September 13, 2012
September 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PaO2
Change in the partial oxygen pressure in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
Measures at Baseline and after 60 min
Secondary Outcomes (4)
O2 %
Measures at Baseline and after 60 min
PaCO2
Measures at Baseline and after 60 min
AaDO2
Measures at Baseline and after 60 min
RV and TLC
Measures at Baseline and after 60 min
Study Arms (2)
Standard Nasal Insufflation of oxygen
ACTIVE COMPARATORStandard Nasal Insufflation of oxygen
Nasal oxygen insufflation with a TNI 20 oxy device
ACTIVE COMPARATORNasal oxygen insufflation with a TNI 20 oxy device
Interventions
Nasal oxygen insufflation with a TNI 20 oxy device
Standard Nasal Insufflation of oxygen
Eligibility Criteria
You may qualify if:
- \- COPD patients with an indication for long-term oxygen therapy Age 30 - 80 years COPD GOLD °III
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Pneumology/USPH Innsbruck, Medical University Innsbruck
Innsbruck, A-6020, Austria
Pneumologie, Medizinische Klinik und Poliklinik I, University Dresden
Dresden, D-01307, Germany
Klinik und Poliklinik für Pneumologie, Inselspital, Universitätsspital Bern
Bern, CH-3010, Switzerland
Related Publications (1)
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.
PMID: 29149867DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian M Kaehler, MD
Pneumology, Medical University Innsbruck
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Pneumology, Clinical Professor
Study Record Dates
First Submitted
September 13, 2012
First Posted
September 18, 2012
Study Start
February 1, 2009
Primary Completion
February 1, 2013
Study Completion
March 1, 2013
Last Updated
September 19, 2012
Record last verified: 2012-09