Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-04-03 @ 8:39 AM
Study NCT ID:
NCT00235456
Status:
COMPLETED
Last Update Posted:
2017-02-10
First Post:
2005-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Supplemental Oxygen Reduces Surgical Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014946', 'term': 'Wound Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'johnsor13@ccf.org', 'phone': '216-444-9950', 'title': 'Roberta Johnson', 'organization': 'Cleveland Clinic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '80% Perioperative Oxygen', 'description': 'Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.\n\nPerioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.', 'otherNumAtRisk': 148, 'otherNumAffected': 0, 'seriousNumAtRisk': 148, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '30% Perioperative Oxygen', 'description': 'Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.\n\nStandard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.', 'otherNumAtRisk': 143, 'otherNumAffected': 0, 'seriousNumAtRisk': 143, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incisional Surgical Wound Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '80% Perioperative Oxygen', 'description': 'Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.\n\nPerioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.'}, {'id': 'OG001', 'title': '30% Perioperative Oxygen', 'description': 'Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.\n\nStandard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.61', 'ciLowerLimit': '0.38', 'ciUpperLimit': '0.98', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '0 to 14 days after surgery', 'description': 'Surgical wounds were defined as infected if they met Centers for Disease Control and Prevention definitions.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Return of Bowel Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '80% Perioperative Oxygen', 'description': 'Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.\n\nPerioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.'}, {'id': 'OG001', 'title': '30% Perioperative Oxygen', 'description': 'Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.\n\nStandard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.54', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'time to event after surgery to discharge from hospital', 'description': 'Time to return of bowel function, measured in days.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Return to Ambulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '80% Perioperative Oxygen', 'description': 'Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.\n\nPerioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.'}, {'id': 'OG001', 'title': '30% Perioperative Oxygen', 'description': 'Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.\n\nStandard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.28', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'time to event after surgery', 'description': 'time to return to ambulation after surgery, measured in days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'First Solid Food Intake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '80% Perioperative Oxygen', 'description': 'Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.\n\nPerioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.'}, {'id': 'OG001', 'title': '30% Perioperative Oxygen', 'description': 'Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.\n\nStandard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.57', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'time to event after surgery', 'description': 'Time to restarting feeding after surgery, measured in days.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Staples Removed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '80% Perioperative Oxygen', 'description': 'Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.\n\nPerioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.'}, {'id': 'OG001', 'title': '30% Perioperative Oxygen', 'description': 'Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.\n\nStandard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '3.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.71', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'time to event after surgery', 'description': 'Time to staples removed, measured in days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '80% Perioperative Oxygen', 'description': 'Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.\n\nPerioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.'}, {'id': 'OG001', 'title': '30% Perioperative Oxygen', 'description': 'Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.\n\nStandard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.7', 'spread': '7', 'groupId': 'OG000'}, {'value': '10.5', 'spread': '4.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'time to hospital discharge after surgery', 'description': 'The number of days patient stayed in the hospital after surgery.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '80% Perioperative Oxygen', 'description': 'Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.\n\nPerioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.'}, {'id': 'FG001', 'title': '30% Perioperative Oxygen', 'description': 'Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.\n\nStandard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '143'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '291', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '80% Perioperative Oxygen', 'description': 'Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.\n\nPerioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.'}, {'id': 'BG001', 'title': '30% Perioperative Oxygen', 'description': 'Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.\n\nStandard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.2', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '62.3', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '63.3', 'spread': '12.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-18', 'studyFirstSubmitDate': '2005-10-06', 'resultsFirstSubmitDate': '2016-06-20', 'studyFirstSubmitQcDate': '2005-10-06', 'lastUpdatePostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-06-20', 'studyFirstPostDateStruct': {'date': '2005-10-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incisional Surgical Wound Infection', 'timeFrame': '0 to 14 days after surgery', 'description': 'Surgical wounds were defined as infected if they met Centers for Disease Control and Prevention definitions.'}], 'secondaryOutcomes': [{'measure': 'Return of Bowel Function', 'timeFrame': 'time to event after surgery to discharge from hospital', 'description': 'Time to return of bowel function, measured in days.'}, {'measure': 'Return to Ambulation', 'timeFrame': 'time to event after surgery', 'description': 'time to return to ambulation after surgery, measured in days'}, {'measure': 'First Solid Food Intake', 'timeFrame': 'time to event after surgery', 'description': 'Time to restarting feeding after surgery, measured in days.'}, {'measure': 'Staples Removed', 'timeFrame': 'time to event after surgery', 'description': 'Time to staples removed, measured in days'}, {'measure': 'Hospital Length of Stay', 'timeFrame': 'time to hospital discharge after surgery', 'description': 'The number of days patient stayed in the hospital after surgery.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['oxygen', 'surgical complications', 'colo-rectal resections'], 'conditions': ['Wound Infection']}, 'referencesModule': {'references': [{'pmid': '16249417', 'type': 'RESULT', 'citation': 'Belda FJ, Aguilera L, Garcia de la Asuncion J, Alberti J, Vicente R, Ferrandiz L, Rodriguez R, Company R, Sessler DI, Aguilar G, Botello SG, Orti R; Spanish Reduccion de la Tasa de Infeccion Quirurgica Group. Supplemental perioperative oxygen and the risk of surgical wound infection: a randomized controlled trial. JAMA. 2005 Oct 26;294(16):2035-42. doi: 10.1001/jama.294.16.2035.'}]}, 'descriptionModule': {'briefSummary': 'Supplemental perioperative oxygen has been reported to halve or double the risk of surgical wound infection. We tested the hypothesis that supplemental oxygen reduces infection risk following colorectal surgery. Colorectal surgery patients (n=300) were randomly assigned to 30% or 80% FiO2 intraoperatively and 6 hours postoperatively. Wound infections were diagnosed by blinded investigators using Centers for Disease Control criteria. Baseline patient characteristics, anesthetic management, and potential confounding factors were recorded. Wound infection rates were compared with chi-square analysis. Logistic regression identified the contribution of potential confounding factors. Surgical wound infection occurred in 24.4% of patients receiving 30% oxygen, but only 14.9% of those receiving 80% oxygen (P\\<0.039). According to logistic regression, the relative risk of infection in patients given supplemental oxygen was 0.46 (P=0.035). Supplemental inspired oxygen reduced wound infection risk by roughly a factor of two. We thus recommend that supplemental oxygen be provided to patients undergoing colorectal surgery.', 'detailedDescription': 'Context: Supplemental perioperative oxygen has been variously reported to halve or double the risk of surgical wound infection.\n\nObjective: We tested the hypothesis that supplemental oxygen reduces infection risk following colorectal surgery.\n\nDesign: Randomized, controlled trial. Setting: Fourteen Spanish hospitals. Patients: Three hundred patients undergoing elective colorectal surgery. Interventions: Patients were randomly assigned to either 30% or 80% FiO2 intraoperatively and for 6 hours after surgery. Anesthetic management and antibiotic administration were standardized.\n\nMain outcome measures: Wound infections were diagnosed by blinded investigators using Centers for Disease Control criteria. Baseline patient characteristics, anesthetic management, and potential confounding factors were recorded. The wound infection rate in the 30% and 80% oxygen groups was compared with chi-square analysis. A logistic regression was used to identify the contribution of potential confounding factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective colorectal resection,\n* Patients having abdominal-peritoneal reconstructions were included, but not those scheduled for minor colon surgery (e.g., polypectomy, isolated colostomy) or laparoscopic surgery.\n\nExclusion Criteria:\n\n* Exclusion criteria included expected surgery time of less than one hour, fever or existing signs of infection, diabetes mellitus (type I or II), HIV infection, weight loss exceeding 20% in the previous three months, serum albumin concentration \\< 30 g/L, and a leukocyte count \\<2500 cells/ml.'}, 'identificationModule': {'nctId': 'NCT00235456', 'briefTitle': 'Supplemental Oxygen Reduces Surgical Infection', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Supplemental Perioperative Oxygen Reduces the Risk of Surgical Wound Infection: A Randomized, Double-blind Trial', 'orgStudyIdInfo': {'id': 'RETIQ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '80% perioperative oxygen', 'description': 'Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.', 'interventionNames': ['Procedure: Perioperative supplemental oxygen']}, {'type': 'PLACEBO_COMPARATOR', 'label': '30% perioperative oxygen', 'description': 'Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.', 'interventionNames': ['Procedure: Standard oxygen']}], 'interventions': [{'name': 'Perioperative supplemental oxygen', 'type': 'PROCEDURE', 'description': 'Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.', 'armGroupLabels': ['80% perioperative oxygen']}, {'name': 'Standard oxygen', 'type': 'PROCEDURE', 'description': 'Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.', 'armGroupLabels': ['30% perioperative oxygen']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'F. Javier Belda, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Clínico Universitario de Valencia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor & Chair', 'investigatorFullName': 'd sessler', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}