Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-02 @ 2:16 AM
Study NCT ID:
NCT01686893
Status:
UNKNOWN
Last Update Posted:
2012-09-19
First Post:
2012-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Safety and Efficacy of Shorttime TNI Treatment in Patients With COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-09-18', 'studyFirstSubmitDate': '2012-09-13', 'studyFirstSubmitQcDate': '2012-09-13', 'lastUpdatePostDateStruct': {'date': '2012-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PaO2', 'timeFrame': 'Measures at Baseline and after 60 min', 'description': 'Change in the partial oxygen pressure in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)'}], 'secondaryOutcomes': [{'measure': 'O2 %', 'timeFrame': 'Measures at Baseline and after 60 min', 'description': 'Change in the oxygen saturation in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)'}, {'measure': 'PaCO2', 'timeFrame': 'Measures at Baseline and after 60 min', 'description': 'Change in the partial carbon dioxide pressure in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)'}, {'measure': 'AaDO2', 'timeFrame': 'Measures at Baseline and after 60 min', 'description': 'Change in the AaDO2 in the peripheral blood at a defined oxygen flow rate (L/min)'}, {'measure': 'RV and TLC', 'timeFrame': 'Measures at Baseline and after 60 min', 'description': 'Safety of the device in COPD °III or IV patients:\n\nNo increase in the residual volume (RV) and the total lung capacity (TLC) \\> 15% of the mean actual value at visits 1 and 2 (measurement 60 + 10 minutes after oxygen insufflation with a TNI system).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Oxygen, Insufflation, COPD, High Flow Treatment'], 'conditions': ['Oxygen Inhalation Therapy']}, 'referencesModule': {'references': [{'pmid': '29149867', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nAt present, there are two different types of devices available for nasal insufflation in clinics:\n\nTNI 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.\n\nTNI 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- COPD patients with an indication for long-term oxygen therapy Age 30 - 80 years COPD GOLD °III\n\nExclusion Criteria:\n\n\\- 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"}, 'identificationModule': {'nctId': 'NCT01686893', 'acronym': 'STIT-1', 'briefTitle': 'Evaluation of Safety and Efficacy of Shorttime TNI Treatment in Patients With COPD', 'organization': {'class': 'OTHER', 'fullName': 'Medical University Innsbruck'}, 'officialTitle': 'STIT-1 Evaluation of Safety and Efficacy of Shorttime TNI Treatment in Patients With COPD', 'orgStudyIdInfo': {'id': 'AN3547'}, 'secondaryIdInfos': [{'id': 'AN 3546', 'type': 'OTHER', 'domain': 'Ethics Committee Innsbruck'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Nasal Insufflation of oxygen', 'description': 'Standard Nasal Insufflation of oxygen', 'interventionNames': ['Device: Standard Nasal Insufflation of oxygen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nasal oxygen insufflation with a TNI 20 oxy device', 'description': 'Nasal oxygen insufflation with a TNI 20 oxy device', 'interventionNames': ['Device: Nasal oxygen insufflation with a TNI 20 oxy device']}], 'interventions': [{'name': 'Nasal oxygen insufflation with a TNI 20 oxy device', 'type': 'DEVICE', 'otherNames': ['TNI 20 oxy'], 'description': 'Nasal oxygen insufflation with a TNI 20 oxy device', 'armGroupLabels': ['Nasal oxygen insufflation with a TNI 20 oxy device']}, {'name': 'Standard Nasal Insufflation of oxygen', 'type': 'DEVICE', 'description': 'Standard Nasal Insufflation of oxygen', 'armGroupLabels': ['Standard Nasal Insufflation of oxygen']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-6020', 'city': 'Innsbruck', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Christian M Kaehler, MD', 'role': 'CONTACT', 'email': 'c.m.kaehler@i-med.ac.at', 'phone': '004351250423255'}], 'facility': 'Pneumology/USPH Innsbruck, Medical University Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': 'D-01307', 'city': 'Dresden', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Michael Halank, MD', 'role': 'CONTACT', 'phone': '0049 351 458 4721'}, {'name': 'Gert Höffken, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Pneumologie, Medizinische Klinik und Poliklinik I, University Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': 'CH-3010', 'city': 'Bern', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Thomas Geiser, MD', 'role': 'CONTACT', 'phone': '0031 632 34 90'}], 'facility': 'Klinik und Poliklinik für Pneumologie, Inselspital, Universitätsspital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'centralContacts': [{'name': 'Christian M Kaehler, MD', 'role': 'CONTACT', 'email': 'c.m.kaehler@i-med.ac.at', 'phone': '004351250423255'}], 'overallOfficials': [{'name': 'Christian M Kaehler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pneumology, Medical University Innsbruck'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Pneumology, Clinical Professor', 'investigatorFullName': 'Univ.-Prof. Dr. Christian M. Kaehler', 'investigatorAffiliation': 'Medical University Innsbruck'}}}}