Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT00366912
Status:
TERMINATED
Last Update Posted:
2009-08-11
First Post:
2006-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Unloading Respiratory Muscles During NIV: Comparison of a Spontaneous and Auto-adjusting Controlled Mode
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D063087', 'term': 'Noninvasive Ventilation'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 10}}, 'statusModule': {'whyStopped': 'No longer recruiting: participants are no longer being recruited or enrolled', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-10', 'studyFirstSubmitDate': '2006-08-18', 'studyFirstSubmitQcDate': '2006-08-18', 'lastUpdatePostDateStruct': {'date': '2009-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Work of breathing, pressure time product'}], 'secondaryOutcomes': [{'measure': 'comfort'}]}, 'conditionsModule': {'keywords': ['work of breathing', 'pressure time product', 'muscle pressures'], 'conditions': ['Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'Measurement of Work of breathing (WOB), as well as pressure time product (PTP) of transdiaphragmatic pressures to evaluate the degree of muscle activity and muscle unloading during non-invasive ventilation.\n\nThe study makes comparison of a new developed auto adjusting controlled mode and a regular spontaneous mode.', 'detailedDescription': 'Non-invasive ventilation (NIV) reduces carbon dioxide in hypercapnic respiratory failure by unloading the respiratory muscles. Spontaneous modes of NIV are usually being used in these situations. Spontaneous modes have the disadvantage, that the patient has to trigger the ventilator. The work to activate the trigger (WT) is estimated to be as high as up to 50% of the total work of breathing dependent on the underlying disease. Elimination of WT would increase the degree of respiratory muscle unloading.\n\nA new pressure controlled mode incorporated into the ventilogic mechanical ventilator (Weinmann, Germany) is capable of self adjusting respiratory parameters in a preset range according to the patient requirements.\n\nAfter a short period where the patients spontaneous respiratory parameters are being analyzed, the ventilator slowly implements a pressure controlled mode that matches the patients requirements.\n\nThis study intends to investigate if this new mode achieves a higher degree of respiratory muscle unloading compared to a spontaneous mode.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy voluntary individuals\n* PFT within normal limits\n\nExclusion Criteria:\n\n* Disease of the upper GI-tract\n* Any form of lung disease or disease of the upper airways\n* Any form of muscular disease, especially neuromuscular disease pregnancy'}, 'identificationModule': {'nctId': 'NCT00366912', 'briefTitle': 'Unloading Respiratory Muscles During NIV: Comparison of a Spontaneous and Auto-adjusting Controlled Mode', 'organization': {'class': 'OTHER', 'fullName': 'Krankenhaus Kloster Grafschaft'}, 'orgStudyIdInfo': {'id': 'Aladin 2006'}}, 'armsInterventionsModule': {'interventions': [{'name': 'non-invasive ventilation', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '57392', 'city': 'Schmallenberg', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Fachkrankenhaus Kloster Grafschaft', 'geoPoint': {'lat': 51.15473, 'lon': 8.28505}}], 'overallOfficials': [{'name': 'Dominic Dellweg, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fachkrankenhaus Kloster Grafschaft'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Krankenhaus Kloster Grafschaft', 'class': 'OTHER'}}}}