Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT00722020
Status:
COMPLETED
Last Update Posted:
2017-08-07
First Post:
2008-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
HFCWO in Hospitalized Asthmatic Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D013224', 'term': 'Status Asthmaticus'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jroberts@winthrop.org', 'phone': '516-663-4600', 'title': 'Jon Roberts, MD', 'organization': 'Winthrop University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'ICU admission and hospital admission time', 'eventGroups': [{'id': 'EG000', 'title': 'HFCWO / VEST', 'description': 'Pediatric patients with primary diagnosis of Asthma received HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment. Patients receive 15 minutes of HFCWO via the Vest.', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Care With Sham Vest', 'description': 'Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.', 'otherNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Primary Endpoint Will be Time to Readiness for Discharge.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HFCWO / VEST Group', 'description': 'Patients will receive HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment.\n\nHigh Frequency Chest Wall Oscillation via Vest (Hill-Rom Vest(tm)): Simultaneous to bronchodilator treatment via nebulizer (regular treatment), patients will receive 15 minutes of HFCWO via the Vest.'}, {'id': 'OG001', 'title': 'Standard Care', 'description': 'Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.\n\nRegular nebulized bronchodilator treatment.: Sham Vest treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.74', 'spread': '.7', 'groupId': 'OG000'}, {'value': '1.75', 'spread': '.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Days in the hospital prior to patient being clinically ready to discharge', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'asthmatic children'}, {'type': 'SECONDARY', 'title': 'Secondary Endpoint Total Hospital Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HFCWO / VEST', 'description': 'Pediatric patients with primary diagnosis of Asthma received HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment. Patients receive 15 minutes of HFCWO via the Vest.'}, {'id': 'OG001', 'title': 'Standard Care With Sham Vest', 'description': 'Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 Days', 'description': 'Seconadary endpoint was Total Hospital length of stay', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HFCWO / VEST Group', 'description': 'Patients will receive HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment.\n\nHigh Frequency Chest Wall Oscillation via Vest (Hill-Rom Vest(tm)): Simultaneous to bronchodilator treatment via nebulizer (regular treatment), patients will receive 15 minutes of HFCWO via the Vest.'}, {'id': 'FG001', 'title': 'Standard Care', 'description': 'Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.\n\nRegular nebulized bronchodilator treatment.: Sham Vest treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HFCWO / VEST', 'description': 'Pediatric patients with primary diagnosis of Asthma received HFCWO therapy via the VEST(TM). Each Vest treatment will be accompanied by a simultaneous nebulized bronchodilator treatment. Patients receive 15 minutes of HFCWO via the Vest.'}, {'id': 'BG001', 'title': 'Standard Care With Sham Vest', 'description': 'Regular nebulized bronchodilator treatment. Sham Vest treatment as investigator is blinded to whether patient actually received Vest treatment.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '8.2', 'spread': '2.0', 'groupId': 'BG001'}, {'value': '8.2', 'spread': '1.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Pediatric patients admitted with diagnosis of Asthma'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-07', 'studyFirstSubmitDate': '2008-07-23', 'resultsFirstSubmitDate': '2015-08-25', 'studyFirstSubmitQcDate': '2008-07-24', 'lastUpdatePostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-10-22', 'studyFirstPostDateStruct': {'date': '2008-07-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Primary Endpoint Will be Time to Readiness for Discharge.', 'timeFrame': '30 days', 'description': 'Days in the hospital prior to patient being clinically ready to discharge'}], 'secondaryOutcomes': [{'measure': 'Secondary Endpoint Total Hospital Length of Stay', 'timeFrame': '30 Days', 'description': 'Seconadary endpoint was Total Hospital length of stay'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'Bronchial Disease', 'Status Asthmaticus', 'High Frequency Chest Wall Oscillation', 'the Vest', 'HFCWO'], 'conditions': ['Bronchial Asthma', 'Asthma', 'Status Asthmaticus']}, 'descriptionModule': {'briefSummary': 'To determine whether or not high frequency chest wall oscillation (in the form of the VestTM) is superior to regular asthma therapy in the management of children hospitalized with moderate to severe asthma.', 'detailedDescription': 'A historically controlled pilot study was conducted in pediatric patients 18 months to 18 years of age hospitalized with a diagnosis of asthma or reactive airway disease and admitted to the pediatric intensive care unit. Upon receiving informed consent, patients were treated with HFCWO therapy via the VEST. The primary endpoint was time to readiness for discharge, lack of need for continued supportive care (e.g., intravenous fluid or oxygen), and bronchodilator treatments spaced at least four hours apart.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '18 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Any pediatric patient between the ages of 18 months and 18 years admitted to Winthrop University Hospital's pediatric floor or intensive care unit with a diagnosis of asthma or reactive airway disease\n\nExclusion Criteria:\n\n* Patients with chronic, comorbid respiratory conditions (e.g., cerebral palsy, cystic fibrosis)\n* Those who regularly use HFCWO\n* Any patient exhibiting an absolute contraindication to HFCWO therapy\n* Absolute contraindications to using HFCWO include head and neck injury prior to stabilization, and active hemorrhage with hemodynamic instability"}, 'identificationModule': {'nctId': 'NCT00722020', 'briefTitle': 'HFCWO in Hospitalized Asthmatic Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hill-Rom'}, 'officialTitle': 'High Frequency Chest Wall Oscillation in Hospital Management of Asthmatic Children', 'orgStudyIdInfo': {'id': 'CR-0078'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vest Arm', 'description': 'HFCWO treatments 2-3 times daily 15 minutes per treatment via the VEST', 'interventionNames': ['Device: VEST']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Historical control for PICU asthma patients'}], 'interventions': [{'name': 'VEST', 'type': 'DEVICE', 'otherNames': ['Hill-Rom Vest(tm)'], 'description': '15 minutes of HFCWO via the Vest 2-3 times daily', 'armGroupLabels': ['Vest Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11501', 'city': 'Long Island City', 'state': 'New York', 'country': 'United States', 'facility': 'Winthrop University Hospital, Winthrop Pediatric Associates', 'geoPoint': {'lat': 40.74482, 'lon': -73.94875}}, {'zip': '11501', 'city': 'Long Island City', 'state': 'New York', 'country': 'United States', 'facility': 'Winthrop University Hospital', 'geoPoint': {'lat': 40.74482, 'lon': -73.94875}}], 'overallOfficials': [{'name': 'Jon Roberts, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Winthrop University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hill-Rom', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}