Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
Study NCT ID:
NCT04278066
Status:
COMPLETED
Last Update Posted:
2021-10-07
First Post:
2020-02-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hyperoxia and Pulmonary Complications After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018496', 'term': 'Hyperoxia'}, {'id': 'D001261', 'term': 'Pulmonary Atelectasis'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-09-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-06', 'studyFirstSubmitDate': '2020-02-17', 'studyFirstSubmitQcDate': '2020-02-17', 'lastUpdatePostDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retrospective study of the average of per and postoperative PaO2 in cardiac surgery', 'timeFrame': 'iles analyzed retrospectily from January 1st, 2015 to December 31, 2019 will be examined'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hyperoxia', 'Cardiac surgery', 'pulmonary complications', 'Lung collapse', 'Post-operative'], 'conditions': ['Hyperoxia']}, 'descriptionModule': {'briefSummary': 'The main objective is to demonstrate that hyperoxia in cardiac surgery increase the occurrence of post-operative pulmonary complications'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patient operated heart surgery with extra-corporal life support', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient (≥18 years old)\n* Patient operated heart surgery with extra-corporal life support\n* Hospitalization in Cardiology intensive and critical care unit\n* Patient operated in HUS between 01/01/2015 and 31/12/2019\n* Subject consent, after information, to the reuse of its data for the purposes of this study\n\nExclusion Criteria:\n\n* Non-consent patient\n* Hypoxemic patient\n* Emergency surgery\n* Patient with post-operative cardiac assist device\n* Patient with guardianship'}, 'identificationModule': {'nctId': 'NCT04278066', 'acronym': 'HYPER-CARDIO', 'briefTitle': 'Hyperoxia and Pulmonary Complications After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Hyper-Cardia Study : Hyperoxia and Pulmonary Complications After Cardiac Surgery', 'orgStudyIdInfo': {'id': '7655'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': "Service d'Anesthésiologie - NHC", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'François FISCHER, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Strasbourg, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}