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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05012267

Acronym

OmeLEtte

Enrollment

Registered

2021-08-19

Start date

2021-03-25

Completion date

2021-10-27

Last updated

2021-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ards

Keywords

prone position, mechanical ventilation, oxygenation

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.

Interventions

OTHER16-hour PP

PP according to previous study

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Ventilator-free days at 60 days	60 days	Number of days from successfully weaning to day 60
Ventilator-free days at 28 days	28 days	Number of days from successfully weaning to day 28

Secondary

Measure	Time frame	Description
ICU and Hospital stay	Hospital admission	Days of stay
PP complications	ICU admission	Proportion of Patients experiencing accidental removal of catheters, endotracheal tube obstruction or any serious adverse event.
Evolution of respiratory parameters	ICU admission	Measurement of mechanical ventilation parameters.
Survival	60 days	Mortality during ICU or hospital admission

Other

Measure	Time frame	Description
Enteral nutrition administration	ICU admission	Nutritional intake.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026