Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT00817804
Status:
COMPLETED
Last Update Posted:
2009-08-19
First Post:
2009-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'adam.seiver@philips.com', 'phone': '760-703-6993', 'title': 'Adam Seiver', 'organization': 'Respironics California'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Terminated before 20 patients enrolled'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'V60 First', 'description': 'Experimental Study device (used as the experimental device) first in the cross-over study', 'otherNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Conventional First', 'description': 'Experimental Study device (used as the experimental device) second in the cross-over study', 'otherNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '10'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Breathing Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V60 First', 'description': 'Experimental Study device (used as the experimental device) first in the cross-over study'}, {'id': 'OG001', 'title': 'Conventional First', 'description': 'Experimental Study device (used as the experimental device) second in the cross-over study'}], 'classes': [{'title': 'V60', 'categories': [{'measurements': [{'value': '10', 'spread': '0', 'groupId': 'OG000'}, {'value': '40', 'spread': '14.1', 'groupId': 'OG001'}]}]}, {'title': 'Conventional', 'categories': [{'measurements': [{'value': '33.3', 'spread': '0', 'groupId': 'OG000'}, {'value': '45', 'spread': '7.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes', 'description': 'Comfort on visual analog scale 0 - 100, 0 is best', 'unitOfMeasure': 'visual analog scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was per protocol'}, {'type': 'SECONDARY', 'title': 'Saturation of Arterial Oxygen', 'paramType': 'NUMBER', 'timeFrame': '30 minutes', 'unitOfMeasure': 'Percent', 'reportingStatus': 'NOT_POSTED', 'anticipatedPostingDate': '2011-12'}, {'type': 'SECONDARY', 'title': 'Respiratory Rate', 'paramType': 'NUMBER', 'timeFrame': '30 minutes', 'description': 'Breathing rate in breaths per minute', 'unitOfMeasure': 'Breaths per minute', 'reportingStatus': 'NOT_POSTED', 'anticipatedPostingDate': '2011-12'}, {'type': 'SECONDARY', 'title': 'Minute Ventilation', 'paramType': 'NUMBER', 'timeFrame': '30 minutes', 'description': 'Liters per minute that the patient breathes', 'unitOfMeasure': 'liters per minute', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Heart Rate', 'paramType': 'NUMBER', 'timeFrame': '30 minutes', 'description': "Beats per minute that the patient's heart is beating", 'unitOfMeasure': 'Beats per minute', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Pressure', 'paramType': 'NUMBER', 'timeFrame': '30 minutes', 'description': 'Systolic and diastolic blood pressure', 'unitOfMeasure': 'mm Hg', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'V60 First', 'description': 'Experimental Study device (used as the experimental device) first in the cross-over study'}, {'id': 'FG001', 'title': 'Conventional First', 'description': 'Experimental Study device (used as the experimental device) second in the cross-over study'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Hospitalized adult patients enrolled between Jan 17 and Mar 3, 2009.', 'preAssignmentDetails': 'Excluded if did not meet inclusion or did meet exclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'V60 First', 'description': 'Experimental Study device (used as the experimental device) first in the cross-over study'}, {'id': 'BG001', 'title': 'Conventional First', 'description': 'Experimental Study device (used as the experimental device) second in the cross-over study'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16.0', 'spread': '0', 'groupId': 'BG000'}, {'value': '11.5', 'spread': '4.9', 'groupId': 'BG001'}, {'value': '13.0', 'spread': '4.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-12', 'studyFirstSubmitDate': '2009-01-03', 'resultsFirstSubmitDate': '2009-05-05', 'studyFirstSubmitQcDate': '2009-01-05', 'lastUpdatePostDateStruct': {'date': '2009-08-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-06-28', 'studyFirstPostDateStruct': {'date': '2009-01-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breathing Comfort', 'timeFrame': '30 minutes', 'description': 'Comfort on visual analog scale 0 - 100, 0 is best'}], 'secondaryOutcomes': [{'measure': 'Saturation of Arterial Oxygen', 'timeFrame': '30 minutes'}, {'measure': 'Respiratory Rate', 'timeFrame': '30 minutes', 'description': 'Breathing rate in breaths per minute'}, {'measure': 'Minute Ventilation', 'timeFrame': '30 minutes', 'description': 'Liters per minute that the patient breathes'}, {'measure': 'Heart Rate', 'timeFrame': '30 minutes', 'description': "Beats per minute that the patient's heart is beating"}, {'measure': 'Blood Pressure', 'timeFrame': '30 minutes', 'description': 'Systolic and diastolic blood pressure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['noninvasive ventilation'], 'conditions': ['Respiratory Insufficiency', 'Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare a new noninvasive ventilator to existing ventilators already used for patient care.', 'detailedDescription': 'This study compares the Respironics California V60 Mask ventilator to conventional noninvasive ventilators in a cross-over study with the patient as his/her own control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 7 years and \\< 18 years\n* Weight \\> 20 kg (44 lbs)\n* Respiratory failure or respiratory insufficiency\n* Ability to cooperate with the investigators\n* Designated adult able to provide Informed Consent\n\nExclusion Criteria:\n\n* An endotracheal tube or tracheostomy in place\n* Hemodynamically instability\n* Prolonged apnea\n* Inability to maintain the airway\n* A recent history of cardiac and or respiratory arrest\n* Acute hemorrhage\n* Multiple organ system failure\n* Undrained pneumothorax\n* High risk for aspiration\n* Metastatic or terminal cancer\n* Do-not-resuscitate orders\n* Inability to clear respiratory secretions\n* Inability to fit a mask\n* Facial surgery, trauma, or deformity\n* Upper gastrointestinal or airway surgery\n* Pregnancy\n* Refractory delirium\n* PaO2 \\< 50 mmHg on present settings\n* Designee unable or unwilling to provide Informed Consent'}, 'identificationModule': {'nctId': 'NCT00817804', 'briefTitle': 'Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators', 'organization': {'class': 'INDUSTRY', 'fullName': 'Respironics, California, Inc.'}, 'officialTitle': 'Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators for Pediatric Patients With Respiratory Failure or Respiratory Insufficiency', 'orgStudyIdInfo': {'id': 'V60-1050766VP v 2.3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'V60 then Conventional', 'description': 'Study device first', 'interventionNames': ['Device: Use of the V60 Mask Ventilator']}, {'type': 'EXPERIMENTAL', 'label': 'Conventional then V60', 'description': 'Conventional device first', 'interventionNames': ['Device: Use of the V60 Mask Ventilator']}], 'interventions': [{'name': 'Use of the V60 Mask Ventilator', 'type': 'DEVICE', 'otherNames': ['V60 is the Philips V60 Ventilator'], 'description': "The V60 Mask Ventilator used to provide noninvasive ventilation. It is compared to the patient's conventional ventilator in a cross-over study. The ventilator settings can range from CPAP to Pressure Support ventilation with values of IPAP and EPAP to match the conventional ventilation on which the patient had been placed.", 'armGroupLabels': ['Conventional then V60', 'V60 then Conventional']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R3E 0Z3', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'GF-221 Health Sciences Centre', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'overallOfficials': [{'name': 'Steven Mink, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manitoba, Winnipeg, Manitoba, Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Respironics, California, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr. Steven Mink', 'oldOrganization': 'Professor of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada'}}}}