Clinical trial NCT05012267: Duration of Prone Position in the Severe Acute Respiratory Syndrome Coronavirus 2 (COVID-19).
Official title: OptiMal pronE Position LEnghT in Patients With acuTE Respiratory Distress Syndrome Due to COVID-19.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ards
Keywords: prone position
mechanical ventilation
oxygenation
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Ventilator-free days at 28 days
timeFrame: 28 days
measure: Ventilator-free days at 60 days
timeFrame: 60 days
Secondary outcomes:
measure: Survival
timeFrame: 60 days
measure: ICU and Hospital stay
timeFrame: Hospital admission
measure: Evolution of respiratory parameters
timeFrame: ICU admission
measure: PP complications
timeFrame: ICU admission
Other outcomes:
measure: Enteral nutrition administration
timeFrame: ICU admission
Locations:
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
Study officials:
affiliation: Hospital Universitario 12 de Octubre
name: Ignacio Sáez, MD
role: PRINCIPAL_INVESTIGATOR
References:
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