Duration of Prone Position in the Severe Acute Respiratory Syndrome Coronavirus 2 (COVID-19).

NCT05012267 | Completed

• 1 other identifier: OMELETTE
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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).

Conditions

Ards

Keywords

prone position; mechanical ventilation; oxygenation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Survival

  60 days

• ICU and Hospital stay

  Hospital admission

• Evolution of respiratory parameters

  ICU admission

• PP complications

  ICU admission

Other Outcomes (1)

• Enteral nutrition administration

  ICU admission

Study Arms (2)

Control group

NO INTERVENTION

48 hours of PP

Experimental group

EXPERIMENTAL

Anytime from 16 hours when PaO2/FiO2 ≥ 150 mmHg with a FiO2 \< 60%

Other: 16-hour PP

Interventions

16-hour PP OTHER

PP according to previous study

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient above 18 year-old.
• Diagnosis of severe ARDS due to COVID-19 under invasive mechanical ventilation,
• Meet criteria for PP: PaO2/FiO2 \< 150 millimeters of mercury column (mmHg), PEEP ≥ 5 Centimeters of Water (cmH2O), FiO2 ≥ 60.

You may not qualify if:

• No consent for the study.
• 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).

Sponsors & Collaborators

• Ignacio Saez de la Fuente: lead

Study Sites (1)

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Related Publications (14)

• 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: 31986257 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.

  PMID: 32919796 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.

  PMID: 25599942 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.

  PMID: 11529210 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.

  PMID: 15738300 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.

  PMID: 16645177 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.

  PMID: 15547166 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.

  PMID: 26585675 BACKGROUND

• 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: 16556697 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.

  PMID: 23688302 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.

  PMID: 25274497 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.

  PMID: 19272543 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.

  PMID: 33551113 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.

  PMID: 32449068 RESULT

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ignacio Sáez, MD

  Hospital Universitario 12 de Octubre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ignacio Saez de la Fuente, MD

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 19, 2021
• Study Start: March 25, 2021
• Primary Completion: October 27, 2021
• Study Completion: October 27, 2021
• Last Updated: October 28, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)