Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
Study NCT ID:
NCT00810459
Status:
COMPLETED
Last Update Posted:
2021-02-03
First Post:
2008-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trilogy Comparison Study - Pediatrics
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': 'Jeff.Jasko@philips.com', 'phone': '412-542-3651', 'title': 'Jeff Jasko', 'organization': 'Philips'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Trilogy Ventilator', 'description': 'Trilogy ventilator\n\nTrilogy Ventilator: Exposure to one hour on the Trilogy ventilator', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard of Care Ventilator', 'description': 'Participants currently prescribed ventilator\n\nStandard of Care: Exposure of one hour on the Participants prescribed ventilator', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comparable Level of Gas Exchange (Measured as Partial Pressure of Carbon Dioxide (CO2) in Arterial, Venous or Capillary Blood)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trilogy Ventilator', 'description': 'Trilogy ventilator\n\nTrilogy Ventilator: Exposure to one hour on the Trilogy ventilator'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants currently prescribed ventilator\n\nStandard of Care: Exposure of one hour on the Participants prescribed ventilator'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '33.3', 'spread': '11.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After one hour of ventilator use', 'description': 'Comparable level of gas exchange (measured as partial pressure of CO2 in arterial, venous or capillary blood)', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Comparable Level of Gas Exchange for Peripheral Capillary Oxygen Saturation (SpO^2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trilogy Ventilator', 'description': 'Trilogy ventilator\n\nTrilogy Ventilator: Exposure to one hour on the Trilog ventilator'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants currently prescribed ventilator\n\nStandard of Care: Exposure of one hour on the Participants prescribed ventilator'}], 'classes': [{'categories': [{'measurements': [{'value': '94.6', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '97.0', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After one hour of ventilator use', 'description': 'Comparable level of gas exchange for SpO\\^2', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trilogy Ventilator', 'description': 'Trilogy ventilator\n\nTrilogy Ventilator: Exposure to one hour on the Trilogy ventilator'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants currently prescribed ventilator\n\nStandard of Care: Exposure of one hour on the Participants prescribed ventilator'}], 'classes': [{'categories': [{'measurements': [{'value': '114.5', 'spread': '26.4', 'groupId': 'OG000'}, {'value': '103.8', 'spread': '18.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 minutes', 'description': 'heart rate as measured by beats per minute', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Minute Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trilogy Ventilator', 'description': 'Trilogy ventilator\n\nTrilogy Ventilator: Exposure to one hour on the Trilogy ventilator'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants currently prescribed ventilator\n\nStandard of Care: Exposure of one hour on the Participants prescribed ventilator'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'spread': '2.25', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '3.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 minutes', 'description': 'Minute ventilation', 'unitOfMeasure': 'Lpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One data point not captured'}, {'type': 'SECONDARY', 'title': 'Tidal Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trilogy Ventilator', 'description': 'Trilogy ventilator\n\nTrilogy Ventilator: Exposure to one hour on the Trilogy ventilator'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants currently prescribed ventilator\n\nStandard of Care: Exposure of one hour on the Participants prescribed ventilator'}], 'classes': [{'categories': [{'measurements': [{'value': '239', 'spread': '221', 'groupId': 'OG000'}, {'value': '226', 'spread': '209', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 minutes', 'description': 'Tidal Volume', 'unitOfMeasure': 'mL/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One data point not captured for a participant'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Trilogy Ventilator First, Then Standard of Care Ventilator', 'description': 'These participants used the Trilogy Ventilator first, then Standard of Care Ventilator'}, {'id': 'FG001', 'title': 'Standard of Care Ventilator First, Then Trilogy Ventilator', 'description': 'Theses participants used the Standard of Care Ventilator first and then Trilogy Ventilator.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'One participant was reconsented to complete the assessment on new software, this participants was not counted twice in the demographics or protocol enrollment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants Consented', 'description': 'All participants consented for the study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'spread': '6.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'dispFirstSubmitDate': '2018-12-06', 'completionDateStruct': {'date': '2009-01-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-14', 'studyFirstSubmitDate': '2008-12-17', 'dispFirstSubmitQcDate': '2018-12-06', 'resultsFirstSubmitDate': '2020-10-12', 'studyFirstSubmitQcDate': '2008-12-17', 'dispFirstPostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-14', 'studyFirstPostDateStruct': {'date': '2008-12-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparable Level of Gas Exchange (Measured as Partial Pressure of Carbon Dioxide (CO2) in Arterial, Venous or Capillary Blood)', 'timeFrame': 'After one hour of ventilator use', 'description': 'Comparable level of gas exchange (measured as partial pressure of CO2 in arterial, venous or capillary blood)'}, {'measure': 'Comparable Level of Gas Exchange for Peripheral Capillary Oxygen Saturation (SpO^2)', 'timeFrame': 'After one hour of ventilator use', 'description': 'Comparable level of gas exchange for SpO\\^2'}], 'secondaryOutcomes': [{'measure': 'Heart Rate', 'timeFrame': '60 minutes', 'description': 'heart rate as measured by beats per minute'}, {'measure': 'Minute Ventilation', 'timeFrame': '60 minutes', 'description': 'Minute ventilation'}, {'measure': 'Tidal Volume', 'timeFrame': '60 minutes', 'description': 'Tidal Volume'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Respiratory Failure']}, 'descriptionModule': {'briefSummary': "The objective of this study (Part II) will be to compare the performance of the Trilogy device and a conventional ventilator (participant's current device). Both devices will be set to the participants' current mode and prescription settings.", 'detailedDescription': 'A. Primary Hypothesis and end-point In patients with respiratory insufficiency, when compared to conventional ventilators, the Trilogy device achieves comparable level of gas exchange (measured as partial pressure of carbon dioxide (CO2) in arterial, venous or capillary blood)and peripheral capillary oxygen saturation, (SpO2) levels during various modes of ventilation.\n\nB. Secondary Hypothesis and end-points In patients with respiratory insufficiency, when compared to conventional ventilators, the Trilogy device achieves comparable breathing pattern (tidal volume, respiratory rate, minute ventilation), hemodynamics (heart rate), and subjective measures of breathing comfort (measured by modified Borg dyspnea scale).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\> 1years of age; \\< 18 years of age\n2. Greater than 5 kg\n3. Considered clinically stable, with low flow oxygen requirements less than 15 LPM (or FIO2 less than 60 %) and PEEP no greater than 10 cm H2O\n4. Requiring mechanical ventilation through nasal/facial mask, tracheostomy or endotracheal tube (ET Tube)\n\nExclusion Criteria:\n\n1. Clinically unstable, i.e.,\n\n 1. Acute Respiratory Failure\n 2. Participants with refractory hypotension defined as systolic blood pressure less than 90 mm Hg despite inotropic agents)\n 3. Uncontrolled cardiac ischemia or arrhythmias\n 4. or as otherwise determined inappropriate for the study as determined by the investigator\n2. Patients suffering from metastatic or terminal cancer and patients with do-not-resuscitate orders\n3. Pregnancy'}, 'identificationModule': {'nctId': 'NCT00810459', 'briefTitle': 'Trilogy Comparison Study - Pediatrics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips Respironics'}, 'officialTitle': 'Trilogy Comparison Study - Pediatrics', 'orgStudyIdInfo': {'id': 'MR-0713-PTRI-SS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trilogy ventilator', 'description': 'Trilogy ventilator', 'interventionNames': ['Device: Trilogy Ventilator']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Participants currently prescribed ventilator', 'interventionNames': ['Device: Standard of Care']}], 'interventions': [{'name': 'Trilogy Ventilator', 'type': 'DEVICE', 'description': 'Exposure to one hour on the Trilog ventilator', 'armGroupLabels': ['Trilogy ventilator']}, {'name': 'Standard of Care', 'type': 'DEVICE', 'description': 'Exposure of one hour on the Participants prescribed ventilator', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'University of Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'overallOfficials': [{'name': 'Steven Mink, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manitoba'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips Respironics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}