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

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.

Completed
ARDS

Other: 16-hour PP

PP according to previous study

Eligibility Criteria

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).

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Spain
Locations

Hospital 12 de Octubre
Madrid, Spain

Ignacio Sáez, MD, Principal Investigator
Hospital Universitario 12 de Octubre

Ignacio Saez de la Fuente
NCT Number
Keywords
Prone position
Mechanical Ventilation
Oxygenation