Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-02 @ 3:21 AM
Study NCT ID:
NCT05387356
Status:
UNKNOWN
Last Update Posted:
2022-05-27
First Post:
2022-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficiency and Complications of the Consequtive Proning in Covid -19 ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}, '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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 31}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-06-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-23', 'studyFirstSubmitDate': '2022-05-23', 'studyFirstSubmitQcDate': '2022-05-23', 'lastUpdatePostDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effects of prone position', 'timeFrame': '15 days', 'description': 'The investigators will evaluate the arterial blood gase results and ventilator settings before after and during prone position'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prone position', 'intensive care unit'], 'conditions': ['Acute Respiratory Distress Syndrome', 'COVID-19 Respiratory Infection']}, 'descriptionModule': {'briefSummary': 'Thirty -one confirmed Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2 ) infected patients with Acute Respiratory Distress Syndrome (ARDS) and placed in prone position(PP) for 3 times (PP1, PP2, PP3)consecutively will be included. Arterial blood gases (ABG), partial pressure of arterial oxygen/ fraction of inspired oxygen (PaO2/FiO2 ) ratios, partial pressure of carbondioxide (PaCO2), positive end expiratory pressure (PEEP), and fraction of inspired oxygen (FiO2) values will be recorded before (bPP), during (dPP)and after (aPP) every prone positioning. Eye, skin, nerve and tube complications related to prone positions wll be recorded'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Intensive care patient population who were intubated a positive test result for SARS-CoV-2 RNA through nasopharyngeal swab and underwent three subsequent prone positions for 16 hours will be enrolled the study. -', 'eligibilityCriteria': 'Inclusion Criteria:\n\na positive test result for SARS-CoV-2 RNA through nasopharyngeal swab and underwent three subsequent prone positions for 16 hours will be enrolled the study. -\n\nExclusion Criteria:\n\nnegative test result for SARS-CoV-2 RNA -'}, 'identificationModule': {'nctId': 'NCT05387356', 'briefTitle': 'Evaluation of the Efficiency and Complications of the Consequtive Proning in Covid -19 ICU', 'organization': {'class': 'OTHER', 'fullName': 'Kecioren Education and Training Hospital'}, 'officialTitle': 'Evaluation of the Efficiency and Complications of the Consequtive Proning in Covid -19 ICU: A Retrospective Study', 'orgStudyIdInfo': {'id': 'Prone Position'}}, 'armsInterventionsModule': {'interventions': [{'name': 'prone position', 'type': 'OTHER', 'description': "thirty-one patients who had a positive test result for SARS-CoV-2 RNA through nasopharyngeal swab and underwent three subsequent prone positions for 16 hours will be enrolled the study. Medical datas of the patients will be obtained from patients' files which are strictly filled during pandemic. Prone position indication of intensive care unit (ICU) is in case of severe ARDS with PaO2/FiO2 \\<150 despite a PEEP \\>10 cmH2O."}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'esra ozayar', 'role': 'CONTACT', 'email': 'eozayar@yahoo.com.tr', 'phone': '905055025497'}], 'facility': 'Health Sciences University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kecioren Education and Training Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assoc. Prof , Anesthesiology and Reanimation Department', 'investigatorFullName': 'ESRA OZAYAR', 'investigatorAffiliation': 'Kecioren Education and Training Hospital'}}}}