Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2025-12-25 @ 12:59 PM
Study NCT ID:
NCT06765759
Status:
COMPLETED
Last Update Posted:
2025-01-09
First Post:
2025-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prone Duration in COVID-19 ARDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D003075', 'term': 'Coitus'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-07', 'studyFirstSubmitDate': '2025-01-03', 'studyFirstSubmitQcDate': '2025-01-07', 'lastUpdatePostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Calculation of PaO2/FiO2 ratio during short and long prone periods', 'timeFrame': 'At each prone session, calculation will be started one hour before the pronation and finished one hour after returning supine.', 'description': 'Partial arterial oxygen pressure/Fraction of inspired oxygen (PaO2/FiO2) ratio changes before, during and after pronation at each group will be calculated.'}], 'secondaryOutcomes': [{'measure': 'Measurement of PaCO2 during short and long prone periods', 'timeFrame': 'At each prone session, measurement will be started one hour before the pronation and finished one hour after returning supine.', 'description': 'Partial arterial carbon dioxide pressure (PaCO2) changes before, during and after pronation at each group will be measured.'}, {'measure': 'Measurement of PEEP during short and long prone periods', 'timeFrame': 'At each prone session, measurement will be started one hour before the pronation and finished one hour after returning supine.', 'description': 'Positive end-expiratory pressure (PEEP) changes before, during and after pronation at each group will be measured.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID - 19', 'Acute Respiratory Distress Syndrome', 'Prone Position', 'Sex'], 'conditions': ['COVID - 19', 'Acute Respiratory Distress Syndrome (ARDS)']}, 'descriptionModule': {'briefSummary': 'The aim of this observational study is to learn the effects of prone position duration on patient outcomes in patients with severe acute respiratory distress syndrome (ARDS) due to Coronavirus Disease - 2019 (COVID-19). The main question it aims to answer is:\n\nDoes the length of prone position duration affect gas exchange in patients with severe ARDS and is there a difference between genders in this regard? The differences in gas exchange between those who have been in prone position for 16-24 hours and those who have been in prone position for 24-36 hours as part of severe ARDS treatment will be examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consisted of Covid-19 ARDS patients hospitalized in the tertiary intensive care unit of a university hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years old\n* hospitalized for more than 48 hours\n* patients diagnosed with COVID-19\n* intubated patients\n* underwent prone positioning for longer than 16 hours starting from the first session\n\nExclusion Criteria:\n\n* Pregnant females\n* Patients under the age of 18\n* Those who did not reach 16 hours duration of prone position for various reasons (unintentional extubation, ventilation problems, hemodynamic instability, cardiac arrest-prearrest)'}, 'identificationModule': {'nctId': 'NCT06765759', 'acronym': 'PRODUR-CARDS', 'briefTitle': 'Prone Duration in COVID-19 ARDS', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'Impact of Prone Position Duration and Sex Differences on Ventilation and Oxygenation in COVID-19 ARDS Patients: a Retrospective Cohort Study.', 'orgStudyIdInfo': {'id': '2023/789'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Short Prone', 'description': 'The group of patients who remained in prone position for 16-24 hours'}, {'label': 'Long Prone', 'description': 'The group of patients who remained in prone position for 24-36 hours'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34153', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'İstanbul University - Cerrahpaşa, Cerrahpaşa Medical Faculty', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Approval was not obtained from the institute's ethics committee for sharing patient data with an international registry."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Oguzhan Kayhan', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}