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

Ards Clinical Trial

— OmeLEtte  

Official title:

OptiMal pronE Position LEnghT in Patients With acuTE Respiratory Distress Syndrome Due to COVID-19.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05012267
• Other study ID #: OMELETTE
• Status: Completed
• Phase: N/A
• Start date: March 25, 2021
• Est. completion date: October 27, 2021

Study information

• Verified date: October 2021
• Source: Hospital Universitario 12 de Octubre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 27, 2021
• Est. primary completion date: October 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Ards

Intervention

Other:
• 16-hour PP
PP according to previous study

Locations

Country	Name	City	State
Spain	Hospital 12 de Octubre	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Ignacio Saez de la Fuente

Country where clinical trial is conducted

Spain, 

References & Publications (14)

Concha P, Treso-Geira M, Esteve-Sala C, Prades-Berengué 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. pii: S0210-5691(21)00001-2. doi: 10 — View 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. Epub 2006 Apr 27. — View 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. — View 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. — View Citation

Guérin 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, Girar — View 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. Spanish. — View 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. — View Citation

Mancebo J, Fernández R, Blanch L, Rialp G, Gordo F, Ferrer M, Rodríguez F, Garro P, Ricart P, Vallverdú I, Gich I, Castaño J, Saura P, Domínguez G, Bonet A, Albert RK. A multicenter trial of prolonged prone ventilation in severe acute respiratory distress — View 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. — View Citation

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. — View Citation

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. — View Citation

Romero CM, Cornejo RA, Gálvez LR, Llanos OP, Tobar EA, Berasaín 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: 1 — View 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 N — View 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. Erratum in: Lancet. 2020 Jan 29;:. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Enteral nutrition administration	Nutritional intake.	ICU admission
Primary	Ventilator-free days at 28 days	Number of days from successfully weaning to day 28	28 days
Primary	Ventilator-free days at 60 days	Number of days from successfully weaning to day 60	60 days
Secondary	Survival	Mortality during ICU or hospital admission	60 days
Secondary	ICU and Hospital stay	Days of stay	Hospital admission
Secondary	Evolution of respiratory parameters	Measurement of mechanical ventilation parameters.	ICU admission
Secondary	PP complications	Proportion of Patients experiencing accidental removal of catheters, endotracheal tube obstruction or any serious adverse event.	ICU admission