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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).
This is a non-comercial, investigator-driven clinical study developed in a single critical care unit.
The 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).
The 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | 48 hours of PP | |
| Experimental group | Experimental | Anytime from 16 hours when PaO2/FiO2 ≥ 150 mmHg with a FiO2 < 60% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 16-hour PP | Other | PP according to previous study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator-free days at 28 days | Number of days from successfully weaning to day 28 | 28 days |
| Ventilator-free days at 60 days | Number of days from successfully weaning to day 60 | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Mortality during ICU or hospital admission | 60 days |
| ICU and Hospital stay | Days of stay | Hospital admission |
| Measure | Description | Time Frame |
|---|---|---|
| Enteral nutrition administration | Nutritional intake. | ICU admission |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ignacio Sáez, MD | Hospital Universitario 12 de Octubre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31986257 | Background | 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. | |
| 32919796 | Background | 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. |
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| ID | Term |
|---|---|
| D055371 | Acute Lung Injury |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Evolution of respiratory parameters | Measurement of mechanical ventilation parameters. | ICU admission |
| PP complications | Proportion of Patients experiencing accidental removal of catheters, endotracheal tube obstruction or any serious adverse event. | ICU admission |
| 25599942 | Background | 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. |
| 11529210 | Background | 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. |
| 15738300 | Background | 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. |
| 16645177 | Background | 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. |
| 15547166 | Background | 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. |
| 26585675 | Background | 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. |
| 16556697 | Result | 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. |
| 23688302 | Result | 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. |
| 25274497 | Result | 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. |
| 19272543 | Result | 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. |
| 33551113 | Result | 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. |
| 32449068 | Result | 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. |