Oxygen Inhalation Therapy | Evaluation of Safety and Efficacy of Shorttime TNI Treatment in Patients With COPD
Oxygen Inhalation Therapy research study
What is the primary objective of this study?
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
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Oxygen Inhalation Therapy
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:Nasal oxygen insufflation with a TNI 20 oxy deviceNasal oxygen insufflation with a TNI 20 oxy device
Device:Standard Nasal Insufflation of oxygenStandard Nasal Insufflation of oxygen
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Standard Nasal Insufflation of oxygenStandard Nasal Insufflation of oxygen
Nasal oxygen insufflation with a TNI 20 oxy deviceNasal oxygen insufflation with a TNI 20 oxy device
Start Date: February 2009
Completed Date: March 2013
Phase: Phase 1
Primary Outcome: PaO2
Secondary Outcome: O2 %
Study sponsors, principal investigator, and references
Principal Investigator: Christian M Kaehler, MD
Lead Sponsor: Medical University Innsbruck