Suspended

STIT-2Evaluation 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

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What is being tested

Nasal insufflation of oxygen

+ Nasal oxygen insufflation with a TNI® 20 oxy device

Device
Who is being recruted

Chronic Disease+8

+ Lung Diseases

+ Lung Diseases, Obstructive

From 30 to 85 Years
See all eligibility criteria
How is the trial designed

Supportive Care Study

Phase 1
Interventional
Study Start: December 2011
See protocol details

Summary

Principal SponsorMedical University Innsbruck
Study ContactChristian M Kaehler, MDMore contacts
Last updated: September 26, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2011

Actual date on which the first participant was enrolled.

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.

Principal SponsorMedical University Innsbruck
Study ContactChristian M Kaehler, MDMore contacts
Last updated: September 26, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 30 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic DiseaseLung DiseasesLung Diseases, ObstructivePathologic ProcessesRespiratory Tract DiseasesSigns and SymptomsSigns and Symptoms, RespiratoryPathological Conditions, Signs and SymptomsDisease AttributesHypercapniaPulmonary Disease, Chronic Obstructive

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Nasal insufflation of oxygen starting at at flow of 0.5 L/min.

Group II

Active Comparator
Device: TNI®20 oxy Nasal insufflation at a constant high flow of 15 L/min with oxygen addition starting at 0.5 L/min

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Recruiting

Christian Kähler

Innsbruck, AustriaOpen Christian Kähler in Google Maps
Recruiting

Klinik für Innere Medizin V, Universitätsklinikum Homburg, University of Homburg/Saar

Homburg, Germany
Recruiting

Klinik und Poliklinik für Pneumologie, Inselspital Berne, University of Berne

Bern, Switzerland
Recruiting soon

Pneumologie, Medizinische Klinik und Poliklinik I, University of Dresden

Dresden, Germany
Suspended4 Study Centers