Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-27 @ 5:01 AM
Study NCT ID:
NCT01777568
Status:
COMPLETED
Last Update Posted:
2019-04-05
First Post:
2012-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Supplemental Oxygen in Colorectal Surgery: A Quality Improvement Project
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010100', 'term': 'Oxygen'}], 'ancestors': [{'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'KURZA@ccf.org', 'phone': '(216) 445-9924', 'title': 'Kurz, M.D., Andrea', 'organization': 'Cleveland Clinic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '30-day postoperatively', 'eventGroups': [{'id': 'EG000', 'title': '30% Oxygen', 'description': 'Inspired oxygen will be maintained at 30%.\n\n30% oxygen: Inspired oxygen will be maintained at 30%.', 'otherNumAtRisk': 2853, 'deathsNumAtRisk': 2853, 'otherNumAffected': 183, 'seriousNumAtRisk': 2853, 'deathsNumAffected': 10, 'seriousNumAffected': 314}, {'id': 'EG001', 'title': '80% Oxygen', 'description': 'Inspired oxygen will be maintained at 80%.\n\n80% oxygen: Inspired oxygen will be maintained at 30%.', 'otherNumAtRisk': 2896, 'deathsNumAtRisk': 2896, 'otherNumAffected': 150, 'seriousNumAtRisk': 2896, 'deathsNumAffected': 20, 'seriousNumAffected': 314}], 'otherEvents': [{'term': 'uperficial SSI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2853, 'numEvents': 183, 'numAffected': 183}, {'groupId': 'EG001', 'numAtRisk': 2896, 'numEvents': 150, 'numAffected': 150}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'SSI (organ space/deep)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2853, 'numEvents': 112, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 2896, 'numEvents': 118, 'numAffected': 118}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anastomotic leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2853, 'numEvents': 36, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 2896, 'numEvents': 34, 'numAffected': 34}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intra-abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2853, 'numEvents': 143, 'numAffected': 143}, {'groupId': 'EG001', 'numAtRisk': 2896, 'numEvents': 133, 'numAffected': 133}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2853, 'numEvents': 94, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 2896, 'numEvents': 96, 'numAffected': 96}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2853, 'numEvents': 43, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 2896, 'numEvents': 43, 'numAffected': 43}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With One or More Composite Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2853', 'groupId': 'OG000'}, {'value': '2896', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '30% Oxygen', 'description': 'Inspired oxygen will be maintained at 30%.\n\n30% oxygen: Inspired oxygen will be maintained at 30%.'}, {'id': 'OG001', 'title': '80% Oxygen', 'description': 'Inspired oxygen will be maintained at 80%.\n\n80% oxygen: Inspired oxygen will be maintained at 30%.'}], 'classes': [{'categories': [{'measurements': [{'value': '314', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.85', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.14', 'estimateComment': 'Relative Risk: 80% (numerator) vs. 30% (denominator)', 'statisticalMethod': 'GEE model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Postoperative 30 days', 'description': 'A composite of complications:\n\n1. surgical sites infection (organ space / deep)\n2. Anastomotic leak\n3. Intra-abdominal abscess\n4. Sepsis\n5. Wound dehiscence\n6. Death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Superficial SSI (Surgical Site Infection)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2853', 'groupId': 'OG000'}, {'value': '2896', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '30% Oxygen', 'description': 'Inspired oxygen will be maintained at 30%.\n\n30% oxygen: Inspired oxygen will be maintained at 30%.'}, {'id': 'OG001', 'title': '80% Oxygen', 'description': 'Inspired oxygen will be maintained at 80%.\n\n80% oxygen: Inspired oxygen will be maintained at 30%.'}], 'classes': [{'categories': [{'measurements': [{'value': '183', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.047', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.01', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Postoperative 30 days', 'description': 'superficial SSI (Surgical Site Infection)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '30% Oxygen', 'description': 'Inspired oxygen will be maintained at 30%.\n\n30% oxygen: Inspired oxygen will be maintained at 30%.'}, {'id': 'FG001', 'title': '80% Oxygen', 'description': 'Inspired oxygen will be maintained at 80%.\n\n80% oxygen: Inspired oxygen will be maintained at 30%.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2853'}, {'groupId': 'FG001', 'numSubjects': '2896'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2853'}, {'groupId': 'FG001', 'numSubjects': '2896'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2853', 'groupId': 'BG000'}, {'value': '2896', 'groupId': 'BG001'}, {'value': '5749', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '30% Oxygen', 'description': 'Inspired oxygen will be maintained at 30%.\n\n30% oxygen: Inspired oxygen will be maintained at 30%.'}, {'id': 'BG001', 'title': '80% Oxygen', 'description': 'Inspired oxygen will be maintained at 80%.\n\n80% oxygen: Inspired oxygen will be maintained at 30%.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52', 'spread': '17', 'groupId': 'BG000'}, {'value': '52', 'spread': '17', 'groupId': 'BG001'}, {'value': '52', 'spread': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1358', 'groupId': 'BG000'}, {'value': '1387', 'groupId': 'BG001'}, {'value': '2745', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1495', 'groupId': 'BG000'}, {'value': '1509', 'groupId': 'BG001'}, {'value': '3004', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '2558', 'groupId': 'BG000'}, {'value': '2627', 'groupId': 'BG001'}, {'value': '5185', 'groupId': 'BG002'}]}]}, {'title': 'Africa American', 'categories': [{'measurements': [{'value': '235', 'groupId': 'BG000'}, {'value': '207', 'groupId': 'BG001'}, {'value': '442', 'groupId': 'BG002'}]}]}, {'title': 'other', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The designated operating-room suite alternated between using either 30% oxygen as tolerated or 80% oxygen for periods of 2 weeks. For example, the first period used 30% oxygen, the second 80% oxygen, and so on. The oxygen concentration during the initial period was randomly designated by the study statistician. But, thereafter, oxygen delivery was not randomized on a per-patient or even per-period basis.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5749}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-02', 'studyFirstSubmitDate': '2012-12-20', 'resultsFirstSubmitDate': '2018-07-16', 'studyFirstSubmitQcDate': '2013-01-28', 'lastUpdatePostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-02', 'studyFirstPostDateStruct': {'date': '2013-01-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With One or More Composite Complications', 'timeFrame': 'Postoperative 30 days', 'description': 'A composite of complications:\n\n1. surgical sites infection (organ space / deep)\n2. Anastomotic leak\n3. Intra-abdominal abscess\n4. Sepsis\n5. Wound dehiscence\n6. Death'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Superficial SSI (Surgical Site Infection)', 'timeFrame': 'Postoperative 30 days', 'description': 'superficial SSI (Surgical Site Infection)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['30% Oxygen Concentration During Colorectal Surgery', '80% Oxygen Concentration During Colorectal Surgery']}, 'referencesModule': {'references': [{'pmid': '31094783', 'type': 'DERIVED', 'citation': 'Cohen B, Ahuja S, Schacham YN, Chelnick D, Mao G, Ali-Sakr Esa W, Maheshwari K, Sessler DI, Turan A. Intraoperative Hyperoxia Does Not Reduce Postoperative Pain: Subanalysis of an Alternating Cohort Trial. Anesth Analg. 2019 Jun;128(6):1160-1166. doi: 10.1213/ANE.0000000000004002.'}, {'pmid': '30865003', 'type': 'DERIVED', 'citation': 'Cohen B, Ruetzler K, Kurz A, Leung S, Rivas E, Ezell J, Mao G, Sessler DI, Turan A. Intra-operative high inspired oxygen fraction does not increase the risk of postoperative respiratory complications: Alternating intervention clinical trial. Eur J Anaesthesiol. 2019 May;36(5):320-326. doi: 10.1097/EJA.0000000000000980.'}, {'pmid': '29397118', 'type': 'DERIVED', 'citation': 'Kurz A, Kopyeva T, Suliman I, Podolyak A, You J, Lewis B, Vlah C, Khatib R, Keebler A, Reigert R, Seuffert M, Muzie L, Drahuschak S, Gorgun E, Stocchi L, Turan A, Sessler DI. Supplemental oxygen and surgical-site infections: an alternating intervention controlled trial. Br J Anaesth. 2018 Jan;120(1):117-126. doi: 10.1016/j.bja.2017.11.003. Epub 2017 Nov 23.'}]}, 'descriptionModule': {'briefSummary': 'Our primary objective is to develop a clinical pathway for care of patients having colorectal surgery at the Clinic. In particular, the investigators would like to determine what intraoperative concentration of oxygen is optimal in our patients.', 'detailedDescription': 'The investigators therefore propose to test the primary hypothesis that supplemental oxygen (80% versus 30%) reduces the risk of a composite of surgical sites infection and potentially oxygen-related wound complications. Secondarily, the investigators will assess the incremental cost benefit of 80% versus 30% oxygen. As a safety measure, enough oxygen will always be given to maintain oxygen saturation (as determined by pulse oximetry) ≥95%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult colorectal surgical patients'}, 'identificationModule': {'nctId': 'NCT01777568', 'briefTitle': 'Supplemental Oxygen in Colorectal Surgery: A Quality Improvement Project', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Supplemental Oxygen and Surgical-site Infections: An Alternating Intervention Controlled Trial.', 'orgStudyIdInfo': {'id': '12-891'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '30% oxygen', 'description': 'Inspired oxygen will be maintained at 30%.', 'interventionNames': ['Drug: 30% oxygen']}, {'type': 'EXPERIMENTAL', 'label': '80% oxygen', 'description': 'Inspired oxygen will be maintained at 80%.', 'interventionNames': ['Drug: 80% oxygen']}], 'interventions': [{'name': '30% oxygen', 'type': 'DRUG', 'description': 'Inspired oxygen will be maintained at 30%.', 'armGroupLabels': ['30% oxygen']}, {'name': '80% oxygen', 'type': 'DRUG', 'description': 'Inspired oxygen will be maintained at 30%.', 'armGroupLabels': ['80% oxygen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Andrea Kurz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cleveand Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Andrea Kurz', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}