OmeLEtte: Duration of Prone Position in the Severe Acute Respiratory Syndrome Coronavirus 2 (COVID-19).
Study Details
Study Description
Brief Summary
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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
No Intervention: Control group 48 hours of PP |
|
Experimental: Experimental group Anytime from 16 hours when PaO2/FiO2 ≥ 150 mmHg with a FiO2 < 60% |
Other: 16-hour PP
PP according to previous study
|
Outcome Measures
Primary Outcome Measures
- Ventilator-free days at 28 days [28 days]
Number of days from successfully weaning to day 28
- Ventilator-free days at 60 days [60 days]
Number of days from successfully weaning to day 60
Secondary Outcome Measures
- Survival [60 days]
Mortality during ICU or hospital admission
- ICU and Hospital stay [Hospital admission]
Days of stay
- Evolution of respiratory parameters [ICU admission]
Measurement of mechanical ventilation parameters.
- PP complications [ICU admission]
Proportion of Patients experiencing accidental removal of catheters, endotracheal tube obstruction or any serious adverse event.
Other Outcome Measures
- Enteral nutrition administration [ICU admission]
Nutritional intake.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient above 18 year-old.
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Diagnosis of severe ARDS due to COVID-19 under invasive mechanical ventilation,
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Meet criteria for PP: PaO2/FiO2 < 150 millimeters of mercury column (mmHg), PEEP ≥ 5 Centimeters of Water (cmH2O), FiO2 ≥ 60.
Exclusion Criteria:
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No consent for the study.
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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).
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Hospital 12 de Octubre | Madrid | Spain | 28041 |
Sponsors and Collaborators
- Ignacio Saez de la Fuente
Investigators
- Principal Investigator: Ignacio Sáez, MD, Hospital Universitario 12 de Octubre
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Epub 2006 Apr 27.
- 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.
- 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.
- 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. Spanish.
- 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.
- Mora-Arteaga JA, Bernal-Ramírez OJ, Rodríguez 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. Review. English, Spanish.
- Ramírez P, Gordón M, Martín-Cerezuela M, Villarreal E, Sancho E, Padrós M, Frasquet J, Leyva G, Molina I, Barrios M, Gimeno S, Castellanos Á. 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. English, Spanish.
- 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. Erratum in: Lancet. 2020 Jan 29;:.
- OMELETTE