Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT04427969
Status:
COMPLETED
Last Update Posted:
2020-11-10
First Post:
2020-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Prone Position on Coronavirus Disease 2019 Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-05', 'size': 82578, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-06-09T08:22', 'hasProtocol': True}, {'date': '2020-06-05', 'size': 81341, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-06-09T08:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-07', 'studyFirstSubmitDate': '2020-06-06', 'studyFirstSubmitQcDate': '2020-06-09', 'lastUpdatePostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intensive care unit stay', 'timeFrame': 'up to 28 days', 'description': 'the duration of icu stay day'}, {'measure': 'short term mortality', 'timeFrame': 'up to 28 days', 'description': 'mortality percent'}], 'secondaryOutcomes': [{'measure': 'blood gases', 'timeFrame': 'up to 24 hours', 'description': 'partial oxygen pressure: mmhg , partial carbondiocsit pressure mmhg'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coronavirus disease 2019', 'prone position'], 'conditions': ['Coronavirus Infection', 'Acute Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '32007143', 'type': 'RESULT', 'citation': 'Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.'}, {'pmid': '23688302', 'type': 'RESULT', 'citation': 'Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.'}, {'pmid': '26493592', 'type': 'RESULT', 'citation': 'Kallet RH. A Comprehensive Review of Prone Position in ARDS. Respir Care. 2015 Nov;60(11):1660-87. doi: 10.4187/respcare.04271.'}, {'pmid': '29068269', 'type': 'RESULT', 'citation': 'Munshi L, Del Sorbo L, Adhikari NKJ, Hodgson CL, Wunsch H, Meade MO, Uleryk E, Mancebo J, Pesenti A, Ranieri VM, Fan E. Prone Position for Acute Respiratory Distress Syndrome. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2017 Oct;14(Supplement_4):S280-S288. doi: 10.1513/AnnalsATS.201704-343OT.'}]}, 'descriptionModule': {'briefSummary': 'the purpose of this study to evaluate the effect of early awake PP (prone position)application on oxygenation and intubation requirement in patients with acute respiratory failure due to coronavirus disease 2019 pneumonia.', 'detailedDescription': "The first group (early prone position-EPP) created for our study was composed of patients who received PP at least 12 hours early (with the first 48 hours) with the oxygen support of the reservoir mask, and the second group (non-EPP ) patients who received oxygen with the reservoir mask but could not be applied early PP due to the patient's incompatibility or rejection.\n\nConventional oxygen therapy applied to all patients was given with a reservoir mask, aiming at oxygen saturation 93% and above, at a flow rate of 6-15 L / min.\n\nDespite all the treatments, the patients who have a follow-up with a respiratory acidosis , oxygen saturation value below 93%, applied non invasive mechanical ventilation, in case of insufficient patient intubated and have invasive mechanical ventilation. In patients who had regression of glasgow coma scale during follow-up, orotracheal intubation was performed and invasive mechanical ventilation was performed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The data of patients over 18 years old who were followed up and treated in the intensive care unit due to acute respiratory failure due to coronavirus disease 2019 pneumonia were retrospectively reviewed.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who developed acute respiratory failure due to coronavirus disease 2019 pneumonia\n* received conventional oxygen therapy with reservoir mask oxygen at the stage of admission to the intensive care unit\n* older than 18 years old\n\nExclusion Criteria:\n\n* patients with respiratory acidosis,\n* partial oxygen pressure/fraction of inspired oxygen ratio below 150,\n* Glasgow Coma Score (GKS) below 12 points,\n* hemodynamic instability,\n* primary pulmonary pathologies other than pneumonia (lung cancer, cardiopulmonary edema, carcinogen syndrome, etc.)\n* patients who underwent non-invasive mechanical ventilation(NIMV) or intubated from admission to intensive care,\n* those who underwent self prone position under 12 hours were not included in the study.'}, 'identificationModule': {'nctId': 'NCT04427969', 'acronym': 'Prone Position', 'briefTitle': 'Early Prone Position on Coronavirus Disease 2019 Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Sisli Hamidiye Etfal Training and Research Hospital'}, 'officialTitle': 'The Effect of Early Prone Position on Prognosis in Acute Respiratory Failure Due to Coronavirus Disease 2019 Pneumonia', 'orgStudyIdInfo': {'id': 'pp34'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EPP', 'description': 'patients who applied early awake prone position for treatment with conventional oxygen supply', 'interventionNames': ['Behavioral: prone position']}, {'label': 'non-EPP', 'description': 'patient who only get conventional oxygen therapy as respiratory supply'}], 'interventions': [{'name': 'prone position', 'type': 'BEHAVIORAL', 'description': 'to lay in prone position at least 12 hour in a day at ICU', 'armGroupLabels': ['EPP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34400', 'city': 'Istanbul', 'state': 'Marmara', 'country': 'Turkey (Türkiye)', 'facility': 'Sisli Etfal Research and Training Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'ayse surhan cinar', 'role': 'STUDY_CHAIR', 'affiliation': 'chief of anesthesia department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sisli Hamidiye Etfal Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'spercialist medical doctor', 'investigatorFullName': 'Mustafa Altınay', 'investigatorAffiliation': 'Sisli Hamidiye Etfal Training and Research Hospital'}}}}