Evaluation of Safety and Efficacy of Shorttime TNI Treatment in Patients With COPD

NCT ID: NCT01686893

Last Updated: 2012-09-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2013-03-31

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

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.

Conditions

Oxygen Inhalation Therapy

Keywords

Oxygen, Insufflation, COPD, High Flow Treatment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Nasal Insufflation of oxygen

Standard Nasal Insufflation of oxygen

Group Type: ACTIVE_COMPARATOR

Standard Nasal Insufflation of oxygen

Intervention Type: DEVICE

Standard Nasal Insufflation of oxygen

Nasal oxygen insufflation with a TNI 20 oxy device

Nasal oxygen insufflation with a TNI 20 oxy device

Group Type: ACTIVE_COMPARATOR

Nasal oxygen insufflation with a TNI 20 oxy device

Intervention Type: DEVICE

Nasal oxygen insufflation with a TNI 20 oxy device

Interventions

Nasal oxygen insufflation with a TNI 20 oxy device

Nasal oxygen insufflation with a TNI 20 oxy device

Intervention Type: DEVICE

Standard Nasal Insufflation of oxygen

Standard Nasal Insufflation of oxygen

Intervention Type: DEVICE

Other Intervention Names

TNI 20 oxy

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University Innsbruck

OTHER

Sponsor Role: lead

Responsible Party

Univ.-Prof. Dr. Christian M. Kaehler

Head of Pneumology, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christian M Kaehler, MD

Role: PRINCIPAL_INVESTIGATOR

Pneumology, Medical University Innsbruck

Locations

Pneumology/USPH Innsbruck, Medical University Innsbruck

Innsbruck, , Austria

Site Status: RECRUITING

Pneumologie, Medizinische Klinik und Poliklinik I, University Dresden

Dresden, , Germany

Site Status: RECRUITING

Klinik und Poliklinik für Pneumologie, Inselspital, Universitätsspital Bern

Bern, , Switzerland

Site Status: RECRUITING

Countries

Austria; Germany; Switzerland

Central Contacts

Christian M Kaehler, MD

Role: CONTACT

Phone: 004351250423255

Email: c.m.kaehler@i-med.ac.at

Facility Contacts

Christian M Kaehler, MD

Role: primary

Michael Halank, MD

Role: primary

Thomas Geiser, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 29149867 (View on PubMed)

Other Identifiers

AN 3546

Identifier Type: OTHER

Identifier Source: secondary_id

AN3547

Identifier Type: -

Identifier Source: org_study_id