Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-01 @ 2:16 PM
Study NCT ID:
NCT05012267
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
2021-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Duration of Prone Position in the Severe Acute Respiratory Syndrome Coronavirus 2 (COVID-19).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055371', 'term': 'Acute Lung Injury'}], 'ancestors': [{'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-27', 'studyFirstSubmitDate': '2021-08-11', 'studyFirstSubmitQcDate': '2021-08-17', 'lastUpdatePostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Enteral nutrition administration', 'timeFrame': 'ICU admission', 'description': 'Nutritional intake.'}], 'primaryOutcomes': [{'measure': 'Ventilator-free days at 28 days', 'timeFrame': '28 days', 'description': 'Number of days from successfully weaning to day 28'}, {'measure': 'Ventilator-free days at 60 days', 'timeFrame': '60 days', 'description': 'Number of days from successfully weaning to day 60'}], 'secondaryOutcomes': [{'measure': 'Survival', 'timeFrame': '60 days', 'description': 'Mortality during ICU or hospital admission'}, {'measure': 'ICU and Hospital stay', 'timeFrame': 'Hospital admission', 'description': 'Days of stay'}, {'measure': 'Evolution of respiratory parameters', 'timeFrame': 'ICU admission', 'description': 'Measurement of mechanical ventilation parameters.'}, {'measure': 'PP complications', 'timeFrame': 'ICU admission', 'description': 'Proportion of Patients experiencing accidental removal of catheters, endotracheal tube obstruction or any serious adverse event.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prone position', 'mechanical ventilation', 'oxygenation'], 'conditions': ['Ards']}, 'referencesModule': {'references': [{'pmid': '31986257', 'type': 'BACKGROUND', 'citation': 'Wang C, Horby PW, Hayden FG, Gao GF. A novel coronavirus outbreak of global health concern. Lancet. 2020 Feb 15;395(10223):470-473. doi: 10.1016/S0140-6736(20)30185-9. Epub 2020 Jan 24. No abstract available.'}, {'pmid': '32919796', 'type': 'BACKGROUND', 'citation': 'Ramirez P, Gordon M, Martin-Cerezuela M, Villarreal E, Sancho E, Padros M, Frasquet J, Leyva G, Molina I, Barrios M, Gimeno S, Castellanos A. Acute respiratory distress syndrome due to COVID-19. Clinical and prognostic features from a medical Critical Care Unit in Valencia, Spain. Med Intensiva (Engl Ed). 2021 Jan-Feb;45(1):27-34. doi: 10.1016/j.medin.2020.06.015. Epub 2020 Jul 11.'}, {'pmid': '25599942', 'type': 'BACKGROUND', 'citation': 'Mora-Arteaga JA, Bernal-Ramirez OJ, Rodriguez SJ. The effects of prone position ventilation in patients with acute respiratory distress syndrome. A systematic review and metaanalysis. Med Intensiva. 2015 Aug-Sep;39(6):359-72. doi: 10.1016/j.medin.2014.11.003. Epub 2015 Jan 17. English, Spanish.'}, {'pmid': '11529210', 'type': 'BACKGROUND', 'citation': 'Gattinoni L, Tognoni G, Pesenti A, Taccone P, Mascheroni D, Labarta V, Malacrida R, Di Giulio P, Fumagalli R, Pelosi P, Brazzi L, Latini R; Prone-Supine Study Group. Effect of prone positioning on the survival of patients with acute respiratory failure. N Engl J Med. 2001 Aug 23;345(8):568-73. doi: 10.1056/NEJMoa010043.'}, {'pmid': '15738300', 'type': 'BACKGROUND', 'citation': 'Mentzelopoulos SD, Roussos C, Zakynthinos SG. Prone position reduces lung stress and strain in severe acute respiratory distress syndrome. Eur Respir J. 2005 Mar;25(3):534-44. doi: 10.1183/09031936.05.00105804.'}, {'pmid': '16645177', 'type': 'BACKGROUND', 'citation': 'Galiatsou E, Kostanti E, Svarna E, Kitsakos A, Koulouras V, Efremidis SC, Nakos G. Prone position augments recruitment and prevents alveolar overinflation in acute lung injury. Am J Respir Crit Care Med. 2006 Jul 15;174(2):187-97. doi: 10.1164/rccm.200506-899OC. Epub 2006 Apr 27.'}, {'pmid': '15547166', 'type': 'BACKGROUND', 'citation': 'Guerin C, Gaillard S, Lemasson S, Ayzac L, Girard R, Beuret P, Palmier B, Le QV, Sirodot M, Rosselli S, Cadiergue V, Sainty JM, Barbe P, Combourieu E, Debatty D, Rouffineau J, Ezingeard E, Millet O, Guelon D, Rodriguez L, Martin O, Renault A, Sibille JP, Kaidomar M. Effects of systematic prone positioning in hypoxemic acute respiratory failure: a randomized controlled trial. JAMA. 2004 Nov 17;292(19):2379-87. doi: 10.1001/jama.292.19.2379.'}, {'pmid': '26585675', 'type': 'BACKGROUND', 'citation': 'Hermosilla J, Aguayo M, Ferreira L. [Total duration of ventilation in the prone position in patients with acute respiratory distress syndrome]. Med Intensiva. 2016 Jan-Feb;40(1):71. doi: 10.1016/j.medin.2015.09.006. Epub 2015 Nov 14. No abstract available. Spanish.'}, {'pmid': '16556697', 'type': 'RESULT', 'citation': 'Mancebo J, Fernandez R, Blanch L, Rialp G, Gordo F, Ferrer M, Rodriguez F, Garro P, Ricart P, Vallverdu I, Gich I, Castano J, Saura P, Dominguez G, Bonet A, Albert RK. A multicenter trial of prolonged prone ventilation in severe acute respiratory distress syndrome. Am J Respir Crit Care Med. 2006 Jun 1;173(11):1233-9. doi: 10.1164/rccm.200503-353OC. Epub 2006 Mar 23.'}, {'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': '25274497', 'type': 'RESULT', 'citation': 'Saez de la Fuente I, Saez de la Fuente J, Quintana Estelles MD, Garcia Gigorro R, Terceros Almanza LJ, Sanchez Izquierdo JA, Montejo Gonzalez JC. Enteral Nutrition in Patients Receiving Mechanical Ventilation in a Prone Position. JPEN J Parenter Enteral Nutr. 2016 Feb;40(2):250-5. doi: 10.1177/0148607114553232. Epub 2014 Oct 1.'}, {'pmid': '19272543', 'type': 'RESULT', 'citation': 'Romero CM, Cornejo RA, Galvez LR, Llanos OP, Tobar EA, Berasain MA, Arellano DH, Larrondo JF, Castro JS. Extended prone position ventilation in severe acute respiratory distress syndrome: a pilot feasibility study. J Crit Care. 2009 Mar;24(1):81-8. doi: 10.1016/j.jcrc.2008.02.005. Epub 2008 May 14.'}, {'pmid': '33551113', 'type': 'RESULT', 'citation': 'Concha P, Treso-Geira M, Esteve-Sala C, Prades-Berengue C, Domingo-Marco J, Roche-Campo F. Invasive mechanical ventilation and prolonged prone position during the COVID-19 pandemic. Med Intensiva (Engl Ed). 2021 Jan 16;46(3):161-3. doi: 10.1016/j.medin.2021.01.001. Online ahead of print. No abstract available. English, Spanish.'}, {'pmid': '32449068', 'type': 'RESULT', 'citation': 'Jochmans S, Mazerand S, Chelly J, Pourcine F, Sy O, Thieulot-Rolin N, Ellrodt O, Mercier Des Rochettes E, Michaud G, Serbource-Goguel J, Vinsonneau C, Vong LVP, Monchi M. Duration of prone position sessions: a prospective cohort study. Ann Intensive Care. 2020 May 24;10(1):66. doi: 10.1186/s13613-020-00683-7.'}]}, 'descriptionModule': {'briefSummary': 'The OMELETTE study is a randomised, controlled, unicentric, open-label study to prove the noninferiority of reduced prone position (PP) sessions (more tan 16 hours) versus prolonged PP (48 hours).', 'detailedDescription': 'This is a non-comercial, investigator-driven clinical study developed in a single critical care unit.\n\nThe study is coordinated by the main investigator from Hospital Universitario 12 de Octubre in Madrid; The sponsorship is performed by Dr. Ignacio Sáez (Hospital Universitario 12 de Octubre).\n\nThe study was planned according to the Good Clinical Practices. Omelette study has been approved by the Ethics Committee. All participating Patients must give informed consent before any study procedure occur.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient above 18 year-old.\n* Diagnosis of severe ARDS due to COVID-19 under invasive mechanical ventilation,\n* Meet criteria for PP: PaO2/FiO2 \\< 150 millimeters of mercury column (mmHg), PEEP ≥ 5 Centimeters of Water (cmH2O), FiO2 ≥ 60.\n\nExclusion Criteria:\n\n* No consent for the study.\n* PP contraindicated (( elevated intracranial pressure, massive hemoptysis, recent tracheal surgery or sternotomy, unstable hemodynamic status, recent pacemaker implantation, severe facial laceration, open abdominal wound, spine, femur or pelvis fracture or pregnancy).'}, 'identificationModule': {'nctId': 'NCT05012267', 'acronym': 'OmeLEtte', 'briefTitle': 'Duration of Prone Position in the Severe Acute Respiratory Syndrome Coronavirus 2 (COVID-19).', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario 12 de Octubre'}, 'officialTitle': 'OptiMal pronE Position LEnghT in Patients With acuTE Respiratory Distress Syndrome Due to COVID-19.', 'orgStudyIdInfo': {'id': 'OMELETTE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': '48 hours of PP'}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Anytime from 16 hours when PaO2/FiO2 ≥ 150 mmHg with a FiO2 \\< 60%', 'interventionNames': ['Other: 16-hour PP']}], 'interventions': [{'name': '16-hour PP', 'type': 'OTHER', 'description': 'PP according to previous study', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Ignacio Sáez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario 12 de Octubre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ignacio Saez de la Fuente', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Ignacio Saez de la Fuente, MD', 'investigatorFullName': 'Ignacio Saez de la Fuente', 'investigatorAffiliation': 'Hospital Universitario 12 de Octubre'}}}}