Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-30 @ 1:06 PM
Study NCT ID:
NCT01090804
Status:
UNKNOWN
Last Update Posted:
2010-03-23
First Post:
2010-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of BreatheMAX Breathing Device on Secretion Clearance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2012-09-12', 'releaseDate': '2012-08-14'}], 'estimatedResultsFirstSubmitDate': '2012-08-14'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'lastUpdateSubmitDate': '2010-03-22', 'studyFirstSubmitDate': '2010-01-07', 'studyFirstSubmitQcDate': '2010-03-22', 'lastUpdatePostDateStruct': {'date': '2010-03-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'secretion wet weight (gram)', 'timeFrame': 'Three hours before, ten hours after treatment and night-time (02.00-07.00 am.)', 'description': 'Airway mucus secretion was collected for three hours before and ten hours after treatment based on an auditory airway secretion sound and collected again at 02.00-07.00 am.The mucus secretion was collected by sterile suctioning technique via tracheostomy tube without adding any saline or sterile water.'}, {'measure': 'viscosity of secretion', 'timeFrame': 'Three hours before and after treatment', 'description': 'The secretion were collected in three hours before and after treatment, It were measured viscosity by First The mucus was gently homogenized by tissue grinder 5 ml (Cw11-205, Cowie, UK) for six minute at 37 degree celsius Second using Micro-Oswald viscometers with a capillary diameter of 0.77 mm for viscosity measure at same temperature in each sample(before and after).'}], 'secondaryOutcomes': [{'measure': 'Heart rate (beat/min)', 'timeFrame': 'Before, during breathing exercise with device and immediate after treatment', 'description': 'Heart rate was monitored before, during and immediate after breathing exercise with BreatheMAX (6-10 beats/set, 10 set/day and rest between ste for 1 minute)'}, {'measure': 'Oxygen saturation (%SpO2)', 'timeFrame': 'Before, during breathing exercise with device and immediate after treatment', 'description': 'Oxygen saturation was monitored before, during and immediate after breathing exercise with BreatheMAX (6-10 beats/set, 10 set/day and rest between set for 1 minute)'}, {'measure': 'Respiratory rate (times/min)', 'timeFrame': 'In rest interval between set (1 minute)', 'description': 'Respiratory rate was measured by manual for 1 minute before, rest interval between set and immediate after breathing exercise with device (during the patients reconnection mechanical ventilation)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['BreatheMAX breathing device', 'Secretion clearance', 'Ventilatory dependence', 'Intubated patients'], 'conditions': ['Lung Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determined effects of BreatheMAX on secretion clearance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* One sign of secretion accumulation in bronchi\n* Stable cardiopulmonary function\n* Good consciousness and good co-operation\n\nExclusion Criteria:\n\n* Massive hemoptysis\n* Pneumothorax (untreated)'}, 'identificationModule': {'nctId': 'NCT01090804', 'acronym': 'ESMOSC', 'briefTitle': 'The Effectiveness of BreatheMAX Breathing Device on Secretion Clearance', 'organization': {'class': 'OTHER', 'fullName': 'Khon Kaen University'}, 'officialTitle': 'The Effectiveness of BreatheMAX Breathing Device on Airway Secretion Clearance in Patients With Ventilatory Dependence', 'orgStudyIdInfo': {'id': '47660279'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'breathing exercise', 'description': 'BreatheMAX breathing device is Water pressure Threshold Bottle. The level of water in the cylinder determines the load for treatment. In the treatment using 20% PNIP (Peak negative inspiratory pressure) was performed with 6-10 breaths/set; 10 set/day', 'interventionNames': ['Device: BreatheMAX breathing device']}], 'interventions': [{'name': 'BreatheMAX breathing device', 'type': 'DEVICE', 'description': 'secretion clearance, breathing exercise', 'armGroupLabels': ['breathing exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40002', 'city': 'Muang', 'state': 'Changwat Khon Kaen', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Sujittra Kluayhomthong, Bachelor', 'role': 'CONTACT', 'email': 'rabbit_tigger@hotmail.com', 'phone': '668-139-0647'}, {'name': 'Chulee CU Jones, Philosophy', 'role': 'CONTACT', 'email': 'chujones46@yahoo.co.uk', 'phone': '664-320-2399'}], 'facility': 'Pulmonary research room of physical therapy department, Faculty of associated medical sciences, Khon Kaen University'}], 'centralContacts': [{'name': 'Miss Sujittra Kluayhomthong, Bachelor', 'role': 'CONTACT', 'email': 'rabbit_tigger@hotmail.com', 'phone': '081-379-0647'}, {'name': 'Mrs. Chulee Jones, Philosophy', 'role': 'CONTACT', 'email': 'Chujones46@yahoo.co.uk', 'phone': '664-320-2399'}], 'overallOfficials': [{'name': 'Sujittra Kluayhomthong, Bachelor', 'role': 'STUDY_CHAIR', 'affiliation': 'Physical Therapy department, Faculty of Associated Medical Sciences, Khon Kaen university'}, {'name': 'Chulee CU Jones, Philosophy', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Physical Therapy Department, Faculty of Associated Medical Sciences, Khon Kaen university, Thailand'}, {'name': 'Wilaiwan Khrisanapant, Philosophy', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of physiology, Faculty of medicine, Khon Kaen university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Khon Kaen University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Khon Kaen university ( Graduate School )', 'oldOrganization': 'Khon Kaen University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2012-08-14', 'type': 'RELEASE'}, {'date': '2012-09-12', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Sujittra Kluayhomthong, Research Student, Khon Kaen University'}}}}