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.
Other: 16-hour PP
PP according to previous study
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).
Hospital 12 de Octubre
Madrid, Spain
Ignacio Sáez, MD, Principal Investigator
Hospital Universitario 12 de Octubre