Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2025-12-27 @ 10:05 PM
Study NCT ID:
NCT01987661
Status:
COMPLETED
Last Update Posted:
2019-02-11
First Post:
2013-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Airtrapping on Sleep and Breathing in Non Invasive Ventilation (NIV) in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}], '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'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-08', 'studyFirstSubmitDate': '2013-11-13', 'studyFirstSubmitQcDate': '2013-11-13', 'lastUpdatePostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sleep efficiency', 'timeFrame': '2 nights', 'description': 'Sleep efficiency is defined by the relation of "time in bed" to "total sleep time" in the overnight polysomnography protocol'}], 'primaryOutcomes': [{'measure': 'breathing frequency', 'timeFrame': '2 nights', 'description': 'breathing frequency measured with the flow signal of a polysomnography during non invasive ventilation over night'}], 'secondaryOutcomes': [{'measure': 'mean pCO2 level', 'timeFrame': '2 nights', 'description': 'mean pCO2 level over night measured with a transcutanous pCO2 monitor (TOSCA)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'NIV', 'Airtrapping', 'Ventimotion2'], 'conditions': ['COPD', 'Hypercapnic Respiratory Failure']}, 'descriptionModule': {'briefSummary': '15 COPD patients will be surveyed in this prospective randomized crossover pilot study concerning non invasive ventilation. Patients will be treated over 2 nights in randomized order with Ventimotion2 (Weinmann) with and without Airtrap Control under Polysomnography (PSG) surveillance including transcutaneous pCO2 measurement. The sleep quality is judged by evaluating the PSG and pCO2 values over night.\n\nTarget parameters are respiratory rate, sleep quality and influence of Airtrap Control on pCO2 values over night.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Stable respiratory situation\n* Clinically required NIV\n* Capable of giving consent\n\nExclusion Criteria:\n\n* Invasive ventilation\n* Any other severe physical disease that requires immediate medical assistance\n* Acute hypercapnic decompensation with pH \\<7.30 in routine BGA\n* Circumstances that doesn't allow mask ventilation (e.g. facial deformation)\n* Participation in a clinical trial within the last 4 weeks\n* Pregnancy or nursing period\n* Drug addiction"}, 'identificationModule': {'nctId': 'NCT01987661', 'briefTitle': 'The Effects of Airtrapping on Sleep and Breathing in Non Invasive Ventilation (NIV) in COPD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Institut für Pneumologie Hagen Ambrock eV'}, 'officialTitle': 'German: Einfluss Von Airtrapping Auf Atmung Und Schlaf Bei Nichtinvasiver Beatmung (NIV) Von COPD Patienten', 'orgStudyIdInfo': {'id': 'Airtrap2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'bilevel ventilation BIPAP ST', 'description': 'one night, BIPAP ST ventilation with individually optimised pressure parameters and supplemental oxygen if necessary.', 'interventionNames': ['Device: BIPAP ST']}, {'type': 'EXPERIMENTAL', 'label': 'BIPAP ST plus Airtrap', 'description': 'one night, BIPAP ST ventilation with "Airtrap control", same pressure parameters and oxygen.', 'interventionNames': ['Device: BIPAP ST', 'Device: Airtrap']}], 'interventions': [{'name': 'BIPAP ST', 'type': 'DEVICE', 'otherNames': ['Ventimotion 2'], 'description': 'non invasive ventilation, individually titrated for each patient, if necessary combined with oxygen, to improve hypercapnic respiratory failure.', 'armGroupLabels': ['BIPAP ST plus Airtrap', 'bilevel ventilation BIPAP ST']}, {'name': 'Airtrap', 'type': 'DEVICE', 'otherNames': ['Ventimotion 2, Weinmann'], 'description': 'Addional to the individally titrated BiPAP ventilation parameters the function "AirTrap Control" is added.\n\nAirTrap Control helps to prevent dynamic hyperinflation and makes it possible for VENTImotion 2 to automatically regulate to the best frequency and expiration time.', 'armGroupLabels': ['BIPAP ST plus Airtrap']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58091', 'city': 'Hagen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Helios Klinik Hagen', 'geoPoint': {'lat': 51.36081, 'lon': 7.47168}}], 'overallOfficials': [{'name': 'Georg Nilius, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helios Klinik Hagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut für Pneumologie Hagen Ambrock eV', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Weinmann Geräte für Medizin GmbH + Co. KG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Helios Klinik Hagen Ambrock, Klinik für Pneumologie', 'investigatorFullName': 'Georg Nilius', 'investigatorAffiliation': 'Institut für Pneumologie Hagen Ambrock eV'}}}}