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STIT-2: Evaluation of Safety and Efficacy of Short-time TNI® Treatment in Patients With COPD and Hypercapnia

NCT ID: NCT01693146

Last Updated: 2012-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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COPD Hypercapnia

Keywords

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Oxygen High Flow COPD Hypercapnia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Nasal insufflation of oxygen

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

Group Type ACTIVE_COMPARATOR

Nasal insufflation of oxygen

Intervention Type DEVICE

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

Nasal oxygen insufflation with a TNI® 20 oxy device

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

Group Type ACTIVE_COMPARATOR

Nasal oxygen insufflation with a TNI® 20 oxy device

Intervention Type DEVICE

Nasal insufflation at a constant high flow of 15 L/min with oxygen addition starting at 0.5 L/min

Interventions

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Nasal oxygen insufflation with a TNI® 20 oxy device

Nasal insufflation at a constant high flow of 15 L/min with oxygen addition starting at 0.5 L/min

Intervention Type DEVICE

Nasal insufflation of oxygen

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TNI Medical AG

INDUSTRY

Sponsor Role collaborator

Medical University Innsbruck

OTHER

Sponsor Role lead

Responsible Party

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Univ.-Prof. Dr. Christian M. Kaehler

a.Univ.-Prod. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian M Kaehler, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University Innsbruck

Locations

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Christian Kähler

Innsbruck, , Austria

Site Status RECRUITING

Pneumologie, Medizinische Klinik und Poliklinik I, University of Dresden

Dresden, , Germany

Site Status NOT_YET_RECRUITING

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

Homburg, , Germany

Site Status RECRUITING

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

Bern, , Switzerland

Site Status RECRUITING

Countries

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Austria Germany Switzerland

Central Contacts

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Christian M Kaehler, MD

Role: CONTACT

Phone: 004351250423255

Email: [email protected]

Facility Contacts

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Christian M Kaehler, MD

Role: primary

Michael Halank, MD

Role: primary

Heinrike Wilkens, MD

Role: primary

Thomas Geiser, MD

Role: primary

References

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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

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UN4484

Identifier Type: OTHER

Identifier Source: secondary_id

UN4484

Identifier Type: -

Identifier Source: org_study_id