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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Ards

Intervention / Treatment
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* Other: 16-hour PP


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>48 hours of PP | |
| Experimental: Experimental group<br>Anytime from 16 hours when PaO2/FiO2 ≥ 150 mmHg with a FiO2 < 60% | Other: 16-hour PP<br>* PP according to previous study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Mortality during ICU or hospital admission | 60 days | 
| ICU and Hospital stay | Days of stay | Hospital admission | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prone position, mechanical ventilation, oxygenation