Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-22 @ 12:01 AM
Study NCT ID:
NCT02582957
Status:
COMPLETED
Last Update Posted:
2024-06-06
First Post:
2015-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sigh Ventilation to Increase Ventilator-Free Days in Victims of Trauma at Risk for Acute Respiratory Distress Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D056586', 'term': 'Acute Chest Syndrome'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RICHARD.ALBERT@cuanschutz.edu', 'phone': '303-602-5011', 'title': 'Dr. Richard Albert', 'organization': 'University of Colorado'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Participants were followed for 28 days', 'description': 'Events were considered serious if any of the following apply:\n\n1. Fatal event\n2. Life threatening event\n3. Re-hospitalization\n4. Event likely contributed to prolonging hospitalization\n5. Disabling or incapacitating\n6. Serious laboratory abnormality with clinical symptoms\n\nEvents were detected through responses to routine questionnaires and medical chart review at study visits and also by spontaneous self-report. Other (Not Including Serious) Adverse Events were not monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Sigh Breaths', 'description': 'Sigh breaths consisting of a Tidal volume (VT) that produces a plateau pressure (Pplat) of 35 cmH2O (or 40 cmH2O in patients with BMIs \\> 35 or in patients with moderate or severe abdominal distension from ascites, blood and/or ileum, or prone patients). The sigh breaths will be delivered once every 6 minutes, as part of usual invasive mechanical ventilation.\n\nSigh breaths: Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 259, 'otherNumAffected': 0, 'seriousNumAtRisk': 259, 'deathsNumAffected': 30, 'seriousNumAffected': 103}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'Usual care, meaning that the treating physician will be free to treat the patient in any way he or she sees fit, including utilizing invasive mechanical ventilation as they wish.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 261, 'otherNumAffected': 0, 'seriousNumAtRisk': 261, 'deathsNumAffected': 46, 'seriousNumAffected': 114}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 23, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 23, 'numAffected': 22}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 22, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal Bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhagic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Brain Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 31, 'numAffected': 31}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ventilator-free Days (VFDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sigh Breaths', 'description': 'Sigh breaths consisting of a Tidal volume (VT) that produces a plateau pressure (Pplat) of 35 cmH2O (or 40 cmH2O in patients with BMIs \\> 35 or in patients with moderate or severe abdominal distension from ascites, blood and/or ileum, or prone patients). The sigh breaths will be delivered once every 6 minutes, as part of usual invasive mechanical ventilation.\n\nSigh breaths: Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Usual care, meaning that the treating physician will be free to treat the patient in any way he or she sees fit, including utilizing invasive mechanical ventilation as they wish.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '25.2'}, {'value': '16.1', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '24.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '28 days', 'description': 'Ventilator-free days (VFDs), defined as the number of days of unassisted breathing to day 28 without having to re-institute invasive ventilation. Patients who died before day 28 were assigned 0 VFDs as were those transferred to a long-term care facility while ventilated.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on participants with available follow-up data'}, {'type': 'SECONDARY', 'title': 'All-cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sigh Breaths', 'description': 'Sigh breaths consisting of a Tidal volume (VT) that produces a plateau pressure (Pplat) of 35 cmH2O (or 40 cmH2O in patients with BMIs \\> 35 or in patients with moderate or severe abdominal distension from ascites, blood and/or ileum, or prone patients). The sigh breaths will be delivered once every 6 minutes, as part of usual invasive mechanical ventilation.\n\nSigh breaths: Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Usual care, meaning that the treating physician will be free to treat the patient in any way he or she sees fit, including utilizing invasive mechanical ventilation as they wish.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'All-cause 28 day mortality', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population based on those with follow-up data available'}, {'type': 'SECONDARY', 'title': 'ICU-free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sigh Breaths', 'description': 'Sigh breaths consisting of a Tidal volume (VT) that produces a plateau pressure (Pplat) of 35 cmH2O (or 40 cmH2O in patients with BMIs \\> 35 or in patients with moderate or severe abdominal distension from ascites, blood and/or ileum, or prone patients). The sigh breaths will be delivered once every 6 minutes, as part of usual invasive mechanical ventilation.\n\nSigh breaths: Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Usual care, meaning that the treating physician will be free to treat the patient in any way he or she sees fit, including utilizing invasive mechanical ventilation as they wish.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '20.6'}, {'value': '11.9', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '20.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '28 days', 'description': 'Number of ICU-free days to day 28 after enrollment', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on participants with available follow-up data'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Complications of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sigh Breaths', 'description': 'Sigh breaths consisting of a Tidal volume (VT) that produces a plateau pressure (Pplat) of 35 cmH2O (or 40 cmH2O in patients with BMIs \\> 35 or in patients with moderate or severe abdominal distension from ascites, blood and/or ileum, or prone patients). The sigh breaths will be delivered once every 6 minutes, as part of usual invasive mechanical ventilation.\n\nSigh breaths: Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Usual care, meaning that the treating physician will be free to treat the patient in any way he or she sees fit, including utilizing invasive mechanical ventilation as they wish.'}], 'classes': [{'title': 'Pneumothorax', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Ventilator-associated pneumonia', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}, {'title': 'Hypotension requiring pressors', 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}]}, {'title': 'Pneumatocele', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Specifically the number of participants experiencing pneumothorax, ventilator-associated pneumonia, hypotension requiring pressors, or pneumatoceles.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on participants with available follow-up data'}, {'type': 'SECONDARY', 'title': 'Discharge Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sigh Breaths', 'description': 'Sigh breaths consisting of a Tidal volume (VT) that produces a plateau pressure (Pplat) of 35 cmH2O (or 40 cmH2O in patients with BMIs \\> 35 or in patients with moderate or severe abdominal distension from ascites, blood and/or ileum, or prone patients). The sigh breaths will be delivered once every 6 minutes, as part of usual invasive mechanical ventilation.\n\nSigh breaths: Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Usual care, meaning that the treating physician will be free to treat the patient in any way he or she sees fit, including utilizing invasive mechanical ventilation as they wish.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Percentage of patients discharged to extended care facilities, on mechanical ventilation, or to in-patient or home hospice', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Requiring Oxygen Therapy at Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sigh Breaths', 'description': 'Sigh breaths consisting of a Tidal volume (VT) that produces a plateau pressure (Pplat) of 35 cmH2O (or 40 cmH2O in patients with BMIs \\> 35 or in patients with moderate or severe abdominal distension from ascites, blood and/or ileum, or prone patients). The sigh breaths will be delivered once every 6 minutes, as part of usual invasive mechanical ventilation.\n\nSigh breaths: Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Usual care, meaning that the treating physician will be free to treat the patient in any way he or she sees fit, including utilizing invasive mechanical ventilation as they wish.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Number of Participants newly requiring continuous oxygen therapy at discharge.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sigh Breaths', 'description': 'Sigh breaths consisting of a Tidal volume (VT) that produces a plateau pressure (Pplat) of 35 cmH2O (or 40 cmH2O in patients with BMIs \\> 35 or in patients with moderate or severe abdominal distension from ascites, blood and/or ileum, or prone patients). The sigh breaths will be delivered once every 6 minutes, as part of usual invasive mechanical ventilation.\n\nSigh breaths: Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation.'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'Usual care, meaning that the treating physician will be free to treat the patient in any way he or she sees fit, including utilizing invasive mechanical ventilation as they wish.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '261'}, {'groupId': 'FG001', 'numSubjects': '263'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '259'}, {'groupId': 'FG001', 'numSubjects': '261'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Patients were recruited in 15 trauma centers in the United States from April, 2016, to September, 2022.', 'preAssignmentDetails': 'All analyses were based on the intention-to-treat principle. Participants were included in the primary analysis if primary endpoint data was available (ventilator-free days (VFDs), defined as the number of days of unassisted breathing to day 28 without having to re-institute invasive ventilation).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '524', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sigh Breaths', 'description': 'Sigh breaths consisting of a Tidal volume (VT) that produces a plateau pressure (Pplat) of 35 cmH2O (or 40 cmH2O in patients with BMIs \\> 35 or in patients with moderate or severe abdominal distension from ascites, blood and/or ileum, or prone patients). The sigh breaths will be delivered once every 6 minutes, as part of usual invasive mechanical ventilation.\n\nSigh breaths: Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation.'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'Usual care, meaning that the treating physician will be free to treat the patient in any way he or she sees fit, including utilizing invasive mechanical ventilation as they wish.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '524', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '43.7', 'spread': '19.1', 'groupId': 'BG000'}, {'value': '44.2', 'spread': '19.2', 'groupId': 'BG001'}, {'value': '43.9', 'spread': '19.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '524', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '394', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '524', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '218', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '439', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '524', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '202', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '405', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', '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': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '524', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '261', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '524', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Smoking status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '524', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Current/Past', 'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}, {'title': 'Never', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}, {'title': 'Unknown/Missing', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Arterial blood gas pH', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'BG000'}, {'value': '243', 'groupId': 'BG001'}, {'value': '477', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7.36', 'spread': '0.08', 'groupId': 'BG000'}, {'value': '7.37', 'spread': '0.08', 'groupId': 'BG001'}, {'value': '7.36', 'spread': '0.08', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pH', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data based on available medical records'}, {'title': 'Arterial blood gas PaCO2', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'BG000'}, {'value': '243', 'groupId': 'BG001'}, {'value': '477', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39.1', 'spread': '7.4', 'groupId': 'BG000'}, {'value': '38.6', 'spread': '7.8', 'groupId': 'BG001'}, {'value': '38.9', 'spread': '7.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data based on available medical records'}, {'title': 'Arterial blood gas PaO2', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'BG000'}, {'value': '243', 'groupId': 'BG001'}, {'value': '477', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '157.4', 'spread': '84.2', 'groupId': 'BG000'}, {'value': '152.5', 'spread': '79.9', 'groupId': 'BG001'}, {'value': '154.9', 'spread': '82.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data based on available medical records'}, {'title': 'Arterial blood gas FIO2', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '228', 'groupId': 'BG001'}, {'value': '458', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '48.2', 'spread': '18.9', 'groupId': 'BG000'}, {'value': '47.1', 'spread': '17.2', 'groupId': 'BG001'}, {'value': '47.6', 'spread': '18.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data based on available medical records'}, {'title': 'P/F ratio', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '228', 'groupId': 'BG001'}, {'value': '458', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '347.6', 'spread': '172.0', 'groupId': 'BG000'}, {'value': '349.8', 'spread': '214.0', 'groupId': 'BG001'}, {'value': '349.2', 'spread': '193.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Ratio', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data based on available medical records'}, {'title': 'Hours on ventilator prior to randomization', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '524', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17.1', 'spread': '5.8', 'groupId': 'BG000'}, {'value': '17.0', 'spread': '5.9', 'groupId': 'BG001'}, {'value': '17.0', 'spread': '5.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'hours', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Injury Severity Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '259', 'groupId': 'BG001'}, {'value': '515', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28.8', 'spread': '12.9', 'groupId': 'BG000'}, {'value': '29.9', 'spread': '11.7', 'groupId': 'BG001'}, {'value': '29.4', 'spread': '12.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Score range, 0 (no injury) to 75 (not survivable).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data based on available medical records'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '524', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28.7', 'spread': '6.4', 'groupId': 'BG000'}, {'value': '28.4', 'spread': '6.5', 'groupId': 'BG001'}, {'value': '28.5', 'spread': '6.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-09', 'size': 442924, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-03T10:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 524}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2022-10-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-13', 'studyFirstSubmitDate': '2015-10-19', 'resultsFirstSubmitDate': '2023-10-29', 'studyFirstSubmitQcDate': '2015-10-20', 'lastUpdatePostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-13', 'studyFirstPostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ventilator-free Days (VFDs)', 'timeFrame': '28 days', 'description': 'Ventilator-free days (VFDs), defined as the number of days of unassisted breathing to day 28 without having to re-institute invasive ventilation. Patients who died before day 28 were assigned 0 VFDs as were those transferred to a long-term care facility while ventilated.'}], 'secondaryOutcomes': [{'measure': 'All-cause Mortality', 'timeFrame': '28 days', 'description': 'All-cause 28 day mortality'}, {'measure': 'ICU-free Days', 'timeFrame': '28 days', 'description': 'Number of ICU-free days to day 28 after enrollment'}, {'measure': 'Number of Participants With Complications of Treatment', 'timeFrame': '28 days', 'description': 'Specifically the number of participants experiencing pneumothorax, ventilator-associated pneumonia, hypotension requiring pressors, or pneumatoceles.'}, {'measure': 'Discharge Status', 'timeFrame': '28 days', 'description': 'Percentage of patients discharged to extended care facilities, on mechanical ventilation, or to in-patient or home hospice'}, {'measure': 'Number of Participants Requiring Oxygen Therapy at Discharge', 'timeFrame': '28 days', 'description': 'Number of Participants newly requiring continuous oxygen therapy at discharge.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ARDS', 'Shock Lung', 'Acute Chest Syndrome', 'Respiratory Distress Syndrome, Adult', 'Respiratory insufficiency', 'Trauma'], 'conditions': ['Acute Respiratory Distress Syndrome']}, 'referencesModule': {'references': [{'pmid': '37877609', 'type': 'DERIVED', 'citation': 'Albert RK, Jurkovich GJ, Connett J, Helgeson ES, Keniston A, Voelker H, Lindberg S, Proper JL, Bochicchio G, Stein DM, Cain C, Tesoriero R, Brown CVR, Davis J, Napolitano L, Carver T, Cipolle M, Cardenas L, Minei J, Nirula R, Doucet J, Miller PR, Johnson J, Inaba K, Kao L. Sigh Ventilation in Patients With Trauma: The SiVent Randomized Clinical Trial. JAMA. 2023 Nov 28;330(20):1982-1990. doi: 10.1001/jama.2023.21739.'}]}, 'descriptionModule': {'briefSummary': 'A randomized, concurrent controlled trial to assess if adding sigh breaths to usual invasive mechanical ventilation of victims of trauma who are at risk of developing ARDS will decrease the number of days they require invasive mechanical ventilation.', 'detailedDescription': 'Patients in intensive care units (ICUs) as a result of injuries resulting from penetrating or non-penetrating trauma who are intubated and receiving invasive mechanical ventilation will be randomized to either usual care or usual care with the addition of sigh breaths given once every 6 minutes. Patients will be randomized to one of the two study arms as soon as possible, but not longer than 24 hours after initiation of invasive mechanical ventilation. Patients will be followed for 28 days to assess ventilator-free days (VFDs), mortality, ICU-free days, and the occurrence of complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients in an intensive care unit (ICU) as a result of injuries resulting from penetrating or non-penetrating trauma who are intubated and receiving invasive mechanical ventilation who also have one or more of the following:\n\n1. Traumatic brain injury\n2. \\> 1 long bone fractures\n3. Shock on arrival in the Emergency Department (systolic BP \\< 90 mmHg)\n4. Lung contusion\n5. Receipt of \\> 6 units of blood\n\nExclusion Criteria:\n\n1. Inability to obtain consent from the patient or his/her legally authorized representative (LAR)\n2. Unwillingness of the treating physician to use sigh ventilation as all treating physicians must have equipoise with respect to the intervention\n3. Age limitations per Institutional Review Board regulations\n4. Undergoing invasive mechanical ventilation for \\> 24 hours, excluding any time during which the patient was being ventilated in the operating room, CT or IR, as this could represent too long a delay in instituting the intervention for it to have a chance of being effective\n5. Presence of malignancy or other irreversible disease or condition for which the six month mortality is estimated to exceed 50% (e.g., chronic liver disease with a Child-Pugh Score of 10-15, malignancy refractory to treatment) as this could affect the clinical course and cloud interpretation of the endpoints\n6. Women who are pregnant (negative pregnancy tests required on women of child-bearing age) per Human Subjects regulations\n7. Prisoners, per Human Subjects regulations\n8. Neurological condition that could impair spontaneous ventilation (e.g., C5 or higher spinal cord injury as this could affect the clinical course and cloud interpretation of the ventilator-free day endpoint\n9. Lack of availability of Dräger Evita Infinity V500 ventilator as this is the only ventilator capable of delivering sigh breaths as described in the protocol\n10. Burns \\> 40% of body surface area as this could affect the clinical course and cloud interpretation of the endpoints\n11. Treating physicians being unwilling to use low VT ventilation strategy when ARDS is diagnosed as low VT ventilation is now considered standard of care for patients with ARDS.\n12. Moribund, not expected to survive 24 hours as this could affect the clinical course and cloud interpretation of the endpoints13. Treating physician's decision to use airway pressure release ventilation (APRV).\n13. Patient not expected to require mechanical ventilation \\> 24 hours (e.g., intubated for alcohol intoxication rather than pulmonary problem)."}, 'identificationModule': {'nctId': 'NCT02582957', 'acronym': 'SiVent', 'briefTitle': 'Sigh Ventilation to Increase Ventilator-Free Days in Victims of Trauma at Risk for Acute Respiratory Distress Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Sigh Ventilation to Increase Ventilator-Free Days in Victims of Trauma at Risk for Acute Respiratory Distress Syndrome', 'orgStudyIdInfo': {'id': '1512M81688'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sigh breaths', 'description': 'Sigh breaths consisting of a Tidal volume (VT) that produces a plateau pressure (Pplat) of 35 cmH2O (or 40 cmH2O in patients with BMIs \\> 35 or in patients with moderate or severe abdominal distension from ascites, blood and/or ileum, or prone patients). The sigh breaths will be delivered once every 6 minutes, as part of usual invasive mechanical ventilation.', 'interventionNames': ['Other: Sigh breaths']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Usual care, meaning that the treating physician will be free to treat the patient in any way he or she sees fit, including utilizing invasive mechanical ventilation as they wish.'}], 'interventions': [{'name': 'Sigh breaths', 'type': 'OTHER', 'description': 'Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation.', 'armGroupLabels': ['Sigh breaths']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93701', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Fresno Community Regional Medical Center', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California (LA County)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego Medical Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Care Health System', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical System Shock Trauma Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63130', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '78701', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'University Medical Center Brackenridge', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern (Parkland)', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical School, Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '53226', 'city': 'Wauwatosa', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.04946, 'lon': -88.00759}}], 'overallOfficials': [{'name': 'Richard Albert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}, {'name': 'University of Colorado, Denver', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}