Ignite Creation Date:
2025-12-24 @ 1:56 PM
Ignite Modification Date:
2026-01-03 @ 7:59 PM
Study NCT ID:
NCT06530095
Status:
COMPLETED
Last Update Posted:
2024-07-31
First Post:
2024-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
We Compared the Covid-19 Acute Respiratory Distress Syndrome (ARDS) Patients Who Applied Prone Positioning for16-24 Hours vs 24-48 Hours
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016684', 'term': 'Prone Position'}], 'ancestors': [{'id': 'D011187', 'term': 'Posture'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2024-07-30', 'studyFirstSubmitQcDate': '2024-07-30', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygen Saturation Index (OSI)', 'timeFrame': '48 hours', 'description': 'OSI is calculated by dividing the product of mean airway pressure (MAP) and FiO2 with SpO2'}, {'measure': 'Oxygenation Index', 'timeFrame': '48 hours', 'description': 'Oxygenation index is calculated as OI = MAP × Fio2 × 100 / Pao2, where MAP indicates mean airway pressure and Fio2 indicates fraction of inspired oxygen'}], 'secondaryOutcomes': [{'measure': 'ICU mortality', 'timeFrame': '28 days', 'description': 'mortality rates during patients admission in the ICU'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Morality', 'Oxygenation Indices', 'Hypoxia']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to understand if there is any improvement on oxygenation of patients diagnosed with Covid-19 ARDS patients when we extend the duration of prone positioning.\n\nSecond outcome of the study is to investigate mortality of patients when we extend the duration of prone positioning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have been admitted in ICU and diagnosed with Covid-19 ARDS.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCOVİD 19 ARDS patients patients who have been intubated for 48 hours and more\n\nExclusion Criteria:\n\nPediatric patients Patients who extubated in less than 48 hours Patients with Lung and pleural malignancies'}, 'identificationModule': {'nctId': 'NCT06530095', 'briefTitle': 'We Compared the Covid-19 Acute Respiratory Distress Syndrome (ARDS) Patients Who Applied Prone Positioning for16-24 Hours vs 24-48 Hours', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital'}, 'officialTitle': "''Impact of Early vs. Delayed Prone Positioning on Oxygenation and Mortality in COVID-19 ARDS Patients: A Retrospective Analysis''", 'orgStudyIdInfo': {'id': '2022/318'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': 'Patients who have been in prone positioning for 16-24 hours', 'interventionNames': ['Other: prone positioning']}, {'label': 'Group B', 'description': 'Patients who have been in prone positioning for 24-48 hours', 'interventionNames': ['Other: prone positioning']}], 'interventions': [{'name': 'prone positioning', 'type': 'OTHER', 'description': 'prone positioning', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34450', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bakirkoy Dr Sadi konuk Research and Training hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}