Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-24 @ 9:23 PM
Study NCT ID:
NCT02999932
Status:
TERMINATED
Last Update Posted:
2023-07-11
First Post:
2016-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Peripheral Oxygen Saturation (SpO2) Directed Oxygen Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria']}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1706}}, 'statusModule': {'whyStopped': 'Slow inclusion', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-08', 'studyFirstSubmitDate': '2016-12-14', 'studyFirstSubmitQcDate': '2016-12-16', 'lastUpdatePostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28-day mortality', 'timeFrame': '28 days', 'description': 'Death within 28 days after inclusion'}], 'secondaryOutcomes': [{'measure': 'ventilator-free time', 'timeFrame': '14 days', 'description': 'Hours free from ventilator'}, {'measure': 'RRT-free time', 'timeFrame': '14 days', 'description': 'Hours free from renal replacment therapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critical Illness']}, 'descriptionModule': {'briefSummary': 'Investigators hypothesized that a relative low SpO2 directed oxygen therapy would reduced the mortality in patients staying longer than 72 hours in ICUs.', 'detailedDescription': 'In fear of harmful effect of hypoxia, oxygen therapy is commonly used, especially in critically ill patients in intensive care units (ICUs). However, hyperoxia can be harmful too. Examples are myocardial infarction (MI) patients and patients resuscitated to return of spontaneous circulation after cardiac arrest. In Air Versus Oxygen in Myocardial Infarction (AVOID) trial, Meyhoff and colleagues proved hyperoxia caused more cardiac injury in patients with ST-elevation MI but without hypoxia. Kilgannon and colleagues found that arterial hyperoxia following resuscitation from cardiac arrest were associated with increased in-hospital mortality, and a pulse oxygen saturation (SpO2) of 94-98% was recommended.\n\nRecently, Panwar and colleagues found that compared to liberal oxygen strategy (SpO2 ≥96%), conservative oxygen strategy (SpO2 of 88%-92%) was feasible in patients receiving invasive mechanical ventilation. Girardis and colleagues found control oxygen therapy (targeting SpO2 of 94%-98% or PaO2 of 70-100mmHg) resulted lower ICU mortality than conventional oxygen therapy (SpO2 ≥97%) in the randomized clinical trial called Oxygen-ICU. However, the Oxygen-ICU trial was single-centered, early-terminated with only 480 patients included and led to an unplanned interim analysis. In this larger multicenter trial, investigators hypothesized that a relative low SpO2 directed oxygen therapy was safe and would reduced the 28-day mortality in patients staying longer than 72 hours in ICUs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18 years or older and admitted into ICU, with expected stay in ICU more than 72 hours or longer.\n\nExclusion Criteria:\n\n* under 18 years old, expected stay in ICU less than 72 hours, unconsented inclusion, ICU readmission, patients with acute exacerbation of chronic obstruction disease, patients with severe acute respiratory distress syndrome (defined as PaO2/FiO2 ≤ 100mmHg and PEEP ≥10cmH2O), decision to withhold life-sustaining treatment, physician forgetting to screen during 12 hours after admission, pregnancy, patients with acute myocardial infarction, paraquat poisoning and patients on extracorporeal membrane oxygenation (ECMO) or planned to be on ECMO.'}, 'identificationModule': {'nctId': 'NCT02999932', 'acronym': 'POSDOT', 'briefTitle': 'Peripheral Oxygen Saturation (SpO2) Directed Oxygen Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'Effect of Low vs High Peripheral Oxygen Saturation (SpO2) Directed Oxygen Therapy on Mortality Among Critically Ill Patients', 'orgStudyIdInfo': {'id': 'WuhanUHICU201701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low SpO2 group', 'description': 'SpO2 90-95%, with FiO2 as low as possible.', 'interventionNames': ['Other: SpO2 directed oxygen therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High SpO2 group', 'description': 'SpO2 96-100%, with FiO2 no lower than 30%.', 'interventionNames': ['Other: SpO2 directed oxygen therapy']}], 'interventions': [{'name': 'SpO2 directed oxygen therapy', 'type': 'OTHER', 'description': 'Oxygen therapy was administered to achieve targeted SpO2.', 'armGroupLabels': ['High SpO2 group', 'Low SpO2 group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '471000', 'city': 'Luoyang', 'state': 'Henan', 'country': 'China', 'facility': 'Department of critical care medicine，Luoyang Central Hospital Affiliated to ZhengZhou University', 'geoPoint': {'lat': 34.67345, 'lon': 112.43684}}, {'zip': '464000', 'city': 'Xinyang', 'state': 'Henan', 'country': 'China', 'facility': 'Department of critical care medicine，Xinyang Central Hospital', 'geoPoint': {'lat': 32.12278, 'lon': 114.06556}}, {'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': "Department of critical care medicine, Henan Provincial People's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Department of critical care medicine, The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '450007', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Department of critical care medicine，Zhengzhou Central Hospital Affiliated to Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '442000', 'city': 'Shiyan', 'state': 'Hubei', 'country': 'China', 'facility': 'Department of critical care medicine, Renmin Hospital of Shiyan City', 'geoPoint': {'lat': 32.6475, 'lon': 110.77806}}, {'zip': '442000', 'city': 'Shiyan', 'state': 'Hubei', 'country': 'China', 'facility': 'Department of critical care medicine, Taihe Hospital', 'geoPoint': {'lat': 32.6475, 'lon': 110.77806}}, {'zip': '430000', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Department of critical care medicine, The Central Hospital of Wuhan', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '430060', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Department of critical care medicine，Renmin Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '430079', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Intensive Care Unit, Hubei Cancer Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '441000', 'city': 'Xiangyang', 'state': 'Hubei', 'country': 'China', 'facility': "Department of critical care medicine, Xiangyang No.1 People's Hospital, Affiliated Hospital of Hubei University of Medicine", 'geoPoint': {'lat': 32.0422, 'lon': 112.14479}}, {'zip': '441021', 'city': 'Xiangyang', 'state': 'Hubei', 'country': 'China', 'facility': 'Department of critical care medicine, XiangYang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science', 'geoPoint': {'lat': 32.0422, 'lon': 112.14479}}], 'overallOfficials': [{'name': 'Shiying Yuan, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wu Jieping Medical Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Xiaobo Yang, MD', 'investigatorAffiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}}}}