Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-03-01 @ 12:32 AM
Study NCT ID:
NCT03657368
Status:
COMPLETED
Last Update Posted:
2025-08-27
First Post:
2018-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ventilation Strategy During General Anesthesia for Orthopedic Surgery: A Quality Improvement Project
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'HANY3@ccf.org', 'phone': '216-444-2250', 'title': 'YanYan Han', 'organization': 'Cleveland Clinic Foundation'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 week.', 'description': 'None observed', 'eventGroups': [{'id': 'EG000', 'title': 'Low Tidal Volume and Low PEEP', 'description': 'tidal volume = 6 ml/kg and PEEP = 5 cmH2O', 'otherNumAtRisk': 727, 'deathsNumAtRisk': 727, 'otherNumAffected': 0, 'seriousNumAtRisk': 727, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'High Tidal Volume and Low PEEP', 'description': 'tidal volume = 10 ml/kg and PEEP = 5 cmH2O', 'otherNumAtRisk': 635, 'deathsNumAtRisk': 635, 'otherNumAffected': 0, 'seriousNumAtRisk': 635, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Low Tidal Volume and High PEEP', 'description': 'tidal volume = 6 ml/kg and PEEP = 8 cmH2O', 'otherNumAtRisk': 799, 'deathsNumAtRisk': 799, 'otherNumAffected': 0, 'seriousNumAtRisk': 799, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'High Tidal Volume and High PEEP', 'description': 'tidal volume = 10 ml/kg and PEEP = 8 cmH2O', 'otherNumAtRisk': 699, 'deathsNumAtRisk': 699, 'otherNumAffected': 0, 'seriousNumAtRisk': 699, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time-weighted Average SaO2/FiO2 Ratio in the Postanesthesia Care Unit (PACU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1362', 'groupId': 'OG000'}, {'value': '1498', 'groupId': 'OG001'}, {'value': '1526', 'groupId': 'OG002'}, {'value': '1334', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'TV = 6 ml/kg', 'description': 'tidal volume = 6 ml/kg'}, {'id': 'OG001', 'title': 'TV = 10 ml/kg', 'description': 'tidal volume = 10 ml/kg'}, {'id': 'OG002', 'title': 'PEEP = 5cmH2O', 'description': 'Positive End-Expiratory Pressure = 5cmH2O'}, {'id': 'OG003', 'title': 'PEEP = 8cmH2O', 'description': 'Positive End-Expiratory Pressure = 8cmH2O'}], 'classes': [{'categories': [{'measurements': [{'value': '355', 'spread': '46', 'groupId': 'OG000'}, {'value': '350', 'spread': '47', 'groupId': 'OG001'}, {'value': '353', 'spread': '46', 'groupId': 'OG002'}, {'value': '352', 'spread': '47', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.042', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '3.5', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '7.3', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.966', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.1', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '3.7', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'After surgery until discharged from PACU or up to 90 minutes', 'description': 'Primary outcome was oxygenation in the postoperative care unit, defined by the peripheral oxygen saturation divided by the fraction of inspired oxygen (SpO2/FiO2 ratio), a validated measure of acute lung injury.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The mean difference was estimated from a linear mixed regression model with surgeries from same patient as repeated measures, after propensity score weighting.'}, {'type': 'SECONDARY', 'title': 'Composite of Serious Postoperative Pulmonary Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1362', 'groupId': 'OG000'}, {'value': '1498', 'groupId': 'OG001'}, {'value': '1526', 'groupId': 'OG002'}, {'value': '1334', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'TV = 6 ml/kg', 'description': 'tidal volume = 6 ml/kg'}, {'id': 'OG001', 'title': 'TV = 10 ml/kg', 'description': 'tidal volume = 10 ml/kg'}, {'id': 'OG002', 'title': 'PEEP = 5cmH2O', 'description': 'PEEP = 5cmH2O'}, {'id': 'OG003', 'title': 'PEEP = 8cmH2O', 'description': 'PEEP = 8cmH2O'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.519', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.2', 'paramValue': '0.93', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.27', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.232', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.2', 'paramValue': '0.87', 'ciLowerLimit': '0.63', 'ciUpperLimit': '1.19', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'After surgery from 2 to 5 days', 'description': 'Postoperative diagnoses will be collected from electronic medical records of patients. Individual chart reviews (blinded to ventilation management) will confirm that terms of the composite are met will be performed.', 'unitOfMeasure': 'person', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Oxygenation in Ward, Defined as Time Weighted Average (TWA) of SaO2/FIO2 Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1362', 'groupId': 'OG000'}, {'value': '1498', 'groupId': 'OG001'}, {'value': '1526', 'groupId': 'OG002'}, {'value': '1334', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'TV = 6 ml/kg', 'description': 'tidal volume = 6 ml/kg'}, {'id': 'OG001', 'title': 'TV = 10 ml/kg', 'description': 'tidal volume = 10 ml/kg'}, {'id': 'OG002', 'title': 'PEEP = 5cmH2O', 'description': 'Positive End-Expiratory Pressure = 5cmH2O'}, {'id': 'OG003', 'title': 'PEEP = 8cmH2O', 'description': 'Positive End-Expiratory Pressure = 8cmH2O'}], 'classes': [{'categories': [{'measurements': [{'value': '428', 'spread': '42', 'groupId': 'OG000'}, {'value': '430', 'spread': '41', 'groupId': 'OG001'}, {'value': '429', 'spread': '41', 'groupId': 'OG002'}, {'value': '429', 'spread': '41', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.217', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.2', 'paramValue': '-2.1', 'ciLowerLimit': '-6.5', 'ciUpperLimit': '2.4', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.660', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.2', 'paramValue': '0.7', 'ciLowerLimit': '-3.7', 'ciUpperLimit': '5.2', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'After surgery from 2 to 5 days', 'description': 'Oxygen administration and SaO2 are normally recorded at 4-hour intervals on surgical wards. The time weighted average (TWA) of overall SaO2/FIO2 ratio will be compared among different ventilation strategies.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Postoperative Hospital Stay by Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1362', 'groupId': 'OG000'}, {'value': '1498', 'groupId': 'OG001'}, {'value': '1526', 'groupId': 'OG002'}, {'value': '1334', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'TV = 6 ml/kg', 'description': 'tidal volume = 6 ml/kg'}, {'id': 'OG001', 'title': 'TV = 10 ml/kg', 'description': 'tidal volume = 10 ml/kg'}, {'id': 'OG002', 'title': 'PEEP = 5cmH2O', 'description': 'Positive End-Expiratory Pressure = 5cmH2O'}, {'id': 'OG003', 'title': 'PEEP = 8cmH2O', 'description': 'Positive End-Expiratory Pressure = 8cmH2O'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '3', 'groupId': 'OG003', 'lowerLimit': '2', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '0.143', 'groupIds': ['OG000', 'OG001'], 'paramType': 'mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.2', 'paramValue': '1.03', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.649', 'groupIds': ['OG002', 'OG003'], 'paramType': 'mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.2', 'paramValue': '0.99', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.05', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'from out of operation room to discharge', 'description': 'The days of postoperative hospitalization, which from out of operation room to discharge from the hospital, an average of 1 week', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patients Need of Oxygen in Ward After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1362', 'groupId': 'OG000'}, {'value': '1498', 'groupId': 'OG001'}, {'value': '1526', 'groupId': 'OG002'}, {'value': '1334', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'TV = 6 ml/kg', 'description': 'tidal volume = 6 ml/kg'}, {'id': 'OG001', 'title': 'TV = 10 ml/kg', 'description': 'tidal volume = 10 ml/kg'}, {'id': 'OG002', 'title': 'PEEP = 5cmH2O', 'description': 'Positive End-Expiratory Pressure= 5cmH2O'}, {'id': 'OG003', 'title': 'PEEP = 8cmH2O', 'description': 'Positive End-Expiratory Pressure = 8cmH2O'}], 'classes': [{'categories': [{'measurements': [{'value': '855', 'groupId': 'OG000'}, {'value': '932', 'groupId': 'OG001'}, {'value': '961', 'groupId': 'OG002'}, {'value': '826', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from out of operation room to discharge from the hospital', 'description': 'number of patients who need of Oxygen in ward after surgery during hospital stay', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patients With Unplanned ICU Admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1362', 'groupId': 'OG000'}, {'value': '1498', 'groupId': 'OG001'}, {'value': '1526', 'groupId': 'OG002'}, {'value': '1334', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'TV = 6 ml/kg', 'description': 'tidal volume = 6 ml/kg'}, {'id': 'OG001', 'title': 'TV = 10 ml/kg', 'description': 'tidal volume = 10 ml/kg'}, {'id': 'OG002', 'title': 'PEEP = 5cmH2O', 'description': 'Positive End-Expiratory Pressure = 5cmH2O'}, {'id': 'OG003', 'title': 'PEEP = 8cmH2O', 'description': 'Positive End-Expiratory Pressure = 8cmH2O'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from out of operation room to discharge from the hospital', 'description': 'number of patients with unplanned ICU admission after surgery in hospital stay', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low Tidal Volume and Low PEEP', 'description': 'Ventilation parameters will be set at tidal volume = 6 ml/ kg predicted body weight, and PEEP = 5 cm water (H2O). (n = 727)\n\nLow tidal Volume: Tidal volume = 6 ml/kg predicted body weight\n\nLow PEEP: PEEP = 5 cm H2O'}, {'id': 'FG001', 'title': 'Low Tidal Volume and High PEEP', 'description': 'Ventilation parameters will be set at tidal volume = 6 ml/kg predicted body weight, and PEEP = 8 cm H2O. (n = 635)\n\nLow tidal Volume: Tidal volume = 6 ml/kg predicted body weight\n\nHigh PEEP: PEEP = 8 cm H2O'}, {'id': 'FG002', 'title': 'High Tidal Volume and Low PEEP', 'description': 'Ventilation parameters will be set at tidal volume = 10 ml/kg predicted body weight, and PEEP = 5cm H2O. (n = 799)\n\nHigh tidal Volume: Tidal volume = 10 ml/kg predicted body weight\n\nLow PEEP: PEEP = 5 cm H2O'}, {'id': 'FG003', 'title': 'High Tidal Volume and High PEEP', 'description': 'Ventilation parameters will be set at tidal volume = 10 ml/kg predicted body weight, and PEEP = 8cm H2O. (n = 699)\n\nHigh tidal Volume: Tidal volume = 10 ml/kg predicted body weight\n\nHigh PEEP: PEEP = 8 cm H2O'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '727'}, {'groupId': 'FG001', 'numSubjects': '635'}, {'groupId': 'FG002', 'numSubjects': '799'}, {'groupId': 'FG003', 'numSubjects': '699'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '727'}, {'groupId': 'FG001', 'numSubjects': '635'}, {'groupId': 'FG002', 'numSubjects': '799'}, {'groupId': 'FG003', 'numSubjects': '699'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '727', 'groupId': 'BG000'}, {'value': '635', 'groupId': 'BG001'}, {'value': '799', 'groupId': 'BG002'}, {'value': '699', 'groupId': 'BG003'}, {'value': '2860', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Tidal Volume and Low PEEP', 'description': 'Ventilation parameters will be set at tidal volume = 6 ml/ kg predicted body weight, and PEEP = 5 cm water (H2O). (n = 727)\n\nLow tidal Volume: Tidal volume = 6 ml/kg predicted body weight\n\nLow PEEP: PEEP = 5 cm H2O'}, {'id': 'BG001', 'title': 'Low Tidal Volume and High PEEP', 'description': 'Ventilation parameters will be set at tidal volume = 6 ml/kg predicted body weight, and PEEP = 8 cm H2O. (n = 635)\n\nLow tidal Volume: Tidal volume = 6 ml/kg predicted body weight\n\nHigh PEEP: PEEP = 8 cm H2O'}, {'id': 'BG002', 'title': 'High Tidal Volume and Low PEEP', 'description': 'Ventilation parameters will be set at tidal volume = 10 ml/kg predicted body weight, and PEEP = 5cm H2O. (n = 799)\n\nHigh tidal Volume: Tidal volume = 10 ml/kg predicted body weight\n\nLow PEEP: PEEP = 5 cm H2O'}, {'id': 'BG003', 'title': 'High Tidal Volume and High PEEP', 'description': 'Ventilation parameters will be set at tidal volume = 10 ml/kg predicted body weight, and PEEP = 8cm H2O. (n = 699)\n\nHigh tidal Volume: Tidal volume = 10 ml/kg predicted body weight\n\nHigh PEEP: PEEP = 8 cm H2O'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'spread': '15', 'groupId': 'BG000'}, {'value': '64', 'spread': '14', 'groupId': 'BG001'}, {'value': '62', 'spread': '15', 'groupId': 'BG002'}, {'value': '63', 'spread': '14', 'groupId': 'BG003'}, {'value': '63', 'spread': '14', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '360', 'groupId': 'BG000'}, {'value': '326', 'groupId': 'BG001'}, {'value': '442', 'groupId': 'BG002'}, {'value': '376', 'groupId': 'BG003'}, {'value': '1504', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '367', 'groupId': 'BG000'}, {'value': '309', 'groupId': 'BG001'}, {'value': '357', 'groupId': 'BG002'}, {'value': '323', 'groupId': 'BG003'}, {'value': '1356', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'race', 'categories': [{'title': 'White', 'measurements': [{'value': '603', 'groupId': 'BG000'}, {'value': '511', 'groupId': 'BG001'}, {'value': '655', 'groupId': 'BG002'}, {'value': '575', 'groupId': 'BG003'}, {'value': '2344', 'groupId': 'BG004'}]}, {'title': 'Black', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}, {'value': '409', 'groupId': 'BG004'}]}, {'title': 'other', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '65', 'groupId': 'BG004'}]}, {'title': 'missing', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '30', 'spread': '7', 'groupId': 'BG000'}, {'value': '30', 'spread': '7', 'groupId': 'BG001'}, {'value': '31', 'spread': '8', 'groupId': 'BG002'}, {'value': '32', 'spread': '7', 'groupId': 'BG003'}, {'value': '31', 'spread': '7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'ASA score', 'classes': [{'categories': [{'title': '1', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}]}, {'title': '2', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}, {'value': '505', 'groupId': 'BG004'}]}, {'title': '3', 'measurements': [{'value': '519', 'groupId': 'BG000'}, {'value': '460', 'groupId': 'BG001'}, {'value': '572', 'groupId': 'BG002'}, {'value': '520', 'groupId': 'BG003'}, {'value': '2071', 'groupId': 'BG004'}]}, {'title': '4 or 5', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '228', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The ASA score refers to the American Society of Anesthesiologists (ASA) Physical Status Classification System, which is used to assess the preoperative physical health of a patient before surgery. ASA score and measure description:\n\nI: A normal, healthy patient. II: A patient with mild systemic disease. III: A patient with severe systemic disease. IV: A patient with severe systemic disease that is a constant threat to life. V: A moribund patient who is not expected to survive without the operation. VI: A declared brain-dead patient whose organs are being removed for donor purposes.', 'unitOfMeasure': 'Participants'}, {'title': 'The total Charlson score', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1', 'groupId': 'BG004', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Charlson Comorbidity Index (CCI), it is a weighted score used to predict the risk of mortality or adverse outcomes by assessing the presence of various comorbid conditions (chronic diseases or medical conditions).\n\nEach condition is assigned a specific weight (from 1 to 6 points) based on the associated risk of mortality. e.g. Dementia scored 1, Metastatic solid tumor scored 6. The total Charlson score is the sum of the CCI for all conditions that a patient has. A higher score indicates a higher risk of death or complications due to the comorbidities. The range is 0 to 37 or higher.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'smoking', 'classes': [{'categories': [{'measurements': [{'value': '369', 'groupId': 'BG000'}, {'value': '346', 'groupId': 'BG001'}, {'value': '404', 'groupId': 'BG002'}, {'value': '341', 'groupId': 'BG003'}, {'value': '1460', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'COPD', 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}, {'value': '377', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Obstructive sleep apnea', 'classes': [{'categories': [{'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}, {'value': '187', 'groupId': 'BG003'}, {'value': '694', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Asthma', 'classes': [{'categories': [{'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}, {'value': '483', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'intraoperative use of Rocuronium', 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000', 'lowerLimit': '50', 'upperLimit': '90'}, {'value': '70', 'groupId': 'BG001', 'lowerLimit': '50', 'upperLimit': '90'}, {'value': '70', 'groupId': 'BG002', 'lowerLimit': '50', 'upperLimit': '90'}, {'value': '65', 'groupId': 'BG003', 'lowerLimit': '50', 'upperLimit': '90'}, {'value': '68', 'groupId': 'BG004', 'lowerLimit': '50', 'upperLimit': '90'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Crystalloids', 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '1.7', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '1.8', 'spread': '0.8', 'groupId': 'BG002'}, {'value': '1.7', 'spread': '0.8', 'groupId': 'BG003'}, {'value': '1.7', 'spread': '0.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'blood loss', 'classes': [{'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000', 'lowerLimit': '50', 'upperLimit': '300'}, {'value': '150', 'groupId': 'BG001', 'lowerLimit': '50', 'upperLimit': '250'}, {'value': '200', 'groupId': 'BG002', 'lowerLimit': '50', 'upperLimit': '300'}, {'value': '150', 'groupId': 'BG003', 'lowerLimit': '50', 'upperLimit': '300'}, {'value': '150', 'groupId': 'BG004', 'lowerLimit': '50', 'upperLimit': '300'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ml', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'transfusion', 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '223', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-20', 'size': 241385, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-03T16:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2860}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2018-08-31', 'resultsFirstSubmitDate': '2024-07-03', 'studyFirstSubmitQcDate': '2018-08-31', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-26', 'studyFirstPostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patients Need of Oxygen in Ward After Surgery', 'timeFrame': 'from out of operation room to discharge from the hospital', 'description': 'number of patients who need of Oxygen in ward after surgery during hospital stay'}, {'measure': 'Patients With Unplanned ICU Admission', 'timeFrame': 'from out of operation room to discharge from the hospital', 'description': 'number of patients with unplanned ICU admission after surgery in hospital stay'}], 'primaryOutcomes': [{'measure': 'Time-weighted Average SaO2/FiO2 Ratio in the Postanesthesia Care Unit (PACU)', 'timeFrame': 'After surgery until discharged from PACU or up to 90 minutes', 'description': 'Primary outcome was oxygenation in the postoperative care unit, defined by the peripheral oxygen saturation divided by the fraction of inspired oxygen (SpO2/FiO2 ratio), a validated measure of acute lung injury.'}], 'secondaryOutcomes': [{'measure': 'Composite of Serious Postoperative Pulmonary Complications', 'timeFrame': 'After surgery from 2 to 5 days', 'description': 'Postoperative diagnoses will be collected from electronic medical records of patients. Individual chart reviews (blinded to ventilation management) will confirm that terms of the composite are met will be performed.'}, {'measure': 'Oxygenation in Ward, Defined as Time Weighted Average (TWA) of SaO2/FIO2 Ratio', 'timeFrame': 'After surgery from 2 to 5 days', 'description': 'Oxygen administration and SaO2 are normally recorded at 4-hour intervals on surgical wards. The time weighted average (TWA) of overall SaO2/FIO2 ratio will be compared among different ventilation strategies.'}, {'measure': 'Length of Postoperative Hospital Stay by Days', 'timeFrame': 'from out of operation room to discharge', 'description': 'The days of postoperative hospitalization, which from out of operation room to discharge from the hospital, an average of 1 week'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Orthopedic Surgery', 'Ventilation']}, 'descriptionModule': {'briefSummary': 'The objective is to determine the optimal intraoperative ventilation strategy among the chosen tidal volume and positive end-expiratory pressure (PEEP) levels, and standardize it in an enhanced recovery pathway for orthopedic surgical patients. In particular, we propose to determine which combination of intraoperative tidal volume and positive end-expiratory pressure is best for patients having elective orthopedic surgery.', 'detailedDescription': 'This is a non-randomized alternating intervention cohort study in which all orthopedic surgery operating rooms will alternate amongst four designated ventilation settings which include two tidal volumes and two PEEP levels. At the end of the four-week sequence, the entire sequence will be repeated 26 times over a 2-year period. Thus, ventilator settings will not be randomized on a per-patient basis, or even among study weeks.\n\nVentilation parameters will be designated at the beginning of each study week. However, clinicians will be free to adjust to whatever ventilation settings they believe is optimal in individual patients to ensure oxygenation and patient safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgery in orthopedic operating rooms 32-37\n* General anesthesia with endotracheal intubation.\n\nExclusion Criteria:\n\n* Non-orthopedic procedures;\n* Intubation before induction of anesthesia.'}, 'identificationModule': {'nctId': 'NCT03657368', 'briefTitle': 'Ventilation Strategy During General Anesthesia for Orthopedic Surgery: A Quality Improvement Project', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Ventilation Strategy During General Anesthesia for Orthopedic Surgery: A Quality Improvement Project', 'orgStudyIdInfo': {'id': '18-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low tidal volume and low PEEP', 'description': 'Ventilation parameters will be set at tidal volume = 6 ml/ kg predicted body weight, and PEEP = 5 cm water (H2O).', 'interventionNames': ['Procedure: Low tidal Volume', 'Procedure: Low PEEP']}, {'type': 'EXPERIMENTAL', 'label': 'Low tidal volume and high PEEP', 'description': 'Ventilation parameters will be set at tidal volume = 6 ml/kg predicted body weight, and PEEP = 8 cm H2O.', 'interventionNames': ['Procedure: Low tidal Volume', 'Procedure: High PEEP']}, {'type': 'EXPERIMENTAL', 'label': 'High tidal volume and low PEEP', 'description': 'Ventilation parameters will be set at tidal volume = 10 ml/kg predicted body weight, and PEEP = 5cm H2O.', 'interventionNames': ['Procedure: High tidal Volume', 'Procedure: Low PEEP']}, {'type': 'EXPERIMENTAL', 'label': 'High tidal volume and high PEEP', 'description': 'Ventilation parameters will be set at tidal volume = 10 ml/kg predicted body weight, and PEEP = 8cm H2O.', 'interventionNames': ['Procedure: High tidal Volume', 'Procedure: High PEEP']}], 'interventions': [{'name': 'Low tidal Volume', 'type': 'PROCEDURE', 'description': 'Tidal volume = 6 ml/kg predicted body weight', 'armGroupLabels': ['Low tidal volume and high PEEP', 'Low tidal volume and low PEEP']}, {'name': 'High tidal Volume', 'type': 'PROCEDURE', 'description': 'Tidal volume = 10 ml/kg predicted body weight', 'armGroupLabels': ['High tidal volume and high PEEP', 'High tidal volume and low PEEP']}, {'name': 'Low PEEP', 'type': 'PROCEDURE', 'description': 'PEEP = 5 cm H2O', 'armGroupLabels': ['High tidal volume and low PEEP', 'Low tidal volume and low PEEP']}, {'name': 'High PEEP', 'type': 'PROCEDURE', 'description': 'PEEP = 8 cm H2O', 'armGroupLabels': ['High tidal volume and high PEEP', 'Low tidal volume and high PEEP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Alparslan Turan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'After publication of the primary manuscript.', 'ipdSharing': 'YES', 'description': 'Data will be shared on a collaborative basis.', 'accessCriteria': 'Data will be shared on a collaborative basis with investigators who plan substantive sub-analyses.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}