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Completed

NCT Number: NCT05012267

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

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).

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Key information

Conditions

ARDS Acute Lung Injury Lung Diseases Lung Injury Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital 12 de Octubre

Madrid, 28041, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

16-hour PP

Other

PP according to previous study

Primary outcomes

  1. Ventilator-free days at 28 days

    Time frame: 28 days

    Number of days from successfully weaning to day 28

  2. Ventilator-free days at 60 days

    Time frame: 60 days

    Number of days from successfully weaning to day 60

Secondary outcomes

  1. Survival

    Time frame: 60 days

    Mortality during ICU or hospital admission

  2. ICU and Hospital stay

    Time frame: Hospital admission

    Days of stay

  3. Evolution of respiratory parameters

    Time frame: ICU admission

    Measurement of mechanical ventilation parameters.

  4. PP complications

    Time frame: ICU admission

    Proportion of Patients experiencing accidental removal of catheters, endotracheal tube obstruction or any serious adverse event.

Other outcomes

  1. Enteral nutrition administration

    Time frame: ICU admission

    Nutritional intake.

Sponsors and collaborators

Lead sponsor

Ignacio Saez de la Fuente

Other

Registry information

Official study title

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

Acronym: OmeLEtte

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 19, 2021
Registry last updated
Oct 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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